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CompletedNCT03437733SHINEUpdated Jun 29, 2025Results posted

Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.

An interventional study of Radiofrequency Ablation in Paroxysmal Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Completed at 5 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by Biosense Webster, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.

Read the detailed description

The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).

02

Conditions studied

  • Paroxysmal Atrial Fibrillation

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Keywords

  • Radiofrequency Ablation
  • Paroxysmal Atrial Fibrillation
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosed with Symptomatic Paroxysmal AF.
  2. Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.
  3. Able and willing to comply with uninterrupted per-protocol anticoagulation requirements
  4. Age 18-75 years.
  5. Able and willing to comply with all pre-, post- and follow-up testing and requirements.
  6. Signed Patient Informed Consent Form.

Exclusion criteria

Exclusion Criteria:

  1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  2. Previous surgical or catheter ablation for AF.
  3. Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region
  4. Previously diagnosed with persistent, longstanding AF and/or continuous AF > 7 days, or > 48 hrs terminated by cardioversion.
  5. Any percutaneous coronary intervention (PCI) within the past 2 months.
  6. Valve repair or replacement and presence of a prosthetic valve.
  7. Any carotid stenting or endarterectomy.
  8. Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months.
  9. Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.
  10. LA antero posterior diameter > 50 mm
  11. Any PV with a diameter ≥ 26 mm
  12. Left Ventricular Ejection Fraction (LVEF) \< 40%.
  13. Contraindication to anticoagulation (e.g. heparin).
  14. History of blood clotting or bleeding abnormalities.
  15. Myocardial infarction within the past 2 months.
  16. Documented thromboembolic event [including transient ischemic attack(TIA)] within the past 12 months.
  17. Rheumatic Heart Disease.
  18. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
  19. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
  20. Unstable angina.
  21. Acute illness or active systemic infection or sepsis.
  22. Diagnosed atrial myxoma or interatrial baffle or patch.
  23. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
  24. Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
  25. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study.
  26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
  27. Enrollment in an investigational study evaluating another device, biologic, or drug.
  28. Has known pulmonary vein stenosis.
  29. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
  30. Presence of an Inferior Vena Cava (IVC) filter
  31. Presence of a condition that precludes vascular access.
  32. Life expectancy or other disease processes likely to limit survival to less than 12 months.
  33. Presenting contra-indication for the devices (e.g. transthoracic echocardiography (TTE), CT, etc.) used in the study, as indicated in the respective instructions for use.

  34. Categorized as a vulnerable population and requires special treatment with respect to safeguards of well-being

    Additional exclusion criteria for Neurological Assessment Evaluable (NAE) subjects:

  35. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
  36. Presence of iron-containing metal fragments in the body
  37. Unresolved pre-existing neurological deficit.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    Intervention

    Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter

    Device: Radiofrequency Ablation

Interventions

  • DeviceRadiofrequency Ablation

    RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter

05

What researchers measure

Primary outcomes

  1. Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis

    A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

    Time frame: Up to 90 days (post initial mapping and ablation procedure)

  2. Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding

    A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

    Time frame: Up to 7 days (post initial mapping and ablation procedure)

  3. Percentage of Participants With Acute Procedural Success

    Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).

    Time frame: Day 1

Secondary outcomes

  1. Number of Participants With Individual PAE From Primary Composite

    A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included death, atrio-esophageal fistula (AE fistula) and pulmonary vein stenosis (PVST); and up to 90 days post procedure which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

    Time frame: Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)

  2. Number of Participants With Serious Adverse Device Effects (SADEs)

    An adverse device effect is an adverse event related to the to the device and or the procedure of the investigational medical device. SADE is an adverse device effect that has resulted in any of the consequences characteristic of an SAE.

    Time frame: Up to 405 Days

  3. Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure

    Serious non-primary adverse event was defined as SAE that are not primary adverse events. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

    Time frame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)

  4. Number of Participants With Non-serious Adverse Events

    An AE is any untoward medical occurrence in participants whether or not related to the investigational medical device.

    Time frame: Up to 405 Days

  5. Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli

    Number of participants with pre-and post-ablation asymptomatic and symptomatic cerebral emboli was reported.

    Time frame: Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)

  6. Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli

    Number of participants with symptomatic and asymptomatic cerebral emboli was reported

    Time frame: Up to 405 Days

  7. Number of Participants With New or Worsening Neurologic Deficits

    Number of participants with new or worsening neurologic deficits was reported.

    Time frame: Pre-procedure, discharge, 1 Month, 3 Month and 6 Month

  8. Number of Participants With NIHSS Scores

    The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed to calculate a patient's total NIHSS score. The patient's total NIHSS score ranges from 0 (minimum) - 42 (maximum). Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke).

    Time frame: Pre-procedure and at discharge (Up to 405 Days)

  9. Number of Participants With MoCA Scores

    Montreal Cognitive Assessment (MoCA) is used for detecting cognitive impairment, the scores range from 0 to 30. A score of 26 or higher is considered normal, patients with mild cognitive impairment (MCI) were scored an average of 22 and patients with significant cognitive impairment (SCI) were scored an average of 16.

    Time frame: Up to 405 Days

  10. Number of Participants With Hospitalization for Cardiovascular Events

    Hospitalization was defined as prolonged stay greater than or equal to (\>=) 2 nights post index procedure or in-patient stay not concurrent with index procedure \>= 1 calendar day. Hospitalization included cardiovascular events due to any cause post index procedure, regardless of protocol-defined serious/non-serious adverse events (AEs) or not. Hence this data was not contributed in serious Adverse events until met the AE definition.

    Time frame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)

  11. Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants

    Percentage of participants with PVI touch-up by balloon and/or focal catheter among all targeted veins and by participants was reported. Most of the participants were ablated by Balloon catheter only while one participant was ablated with both Balloon and Focal catheters.

    Time frame: Up to 405 Days

  12. Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers

    Percentage of participants with use of focal catheter ablation for non-PV triggers was reported.

    Time frame: Up to 405 Days

  13. Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL

    Percentage of participants with six-month arrythmia recurrence \[defined as freedom from documented symptomatic or asymptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atypical (left side) atrial flutter (AFL) episodes (episodes \>30 seconds on arrhythmia monitoring device from Day 91 to 180 post the index procedure)\] was reported.

    Time frame: Up to 6 Months

  14. Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL

    Twelve-month Arrythmia recurrence is defined as a documented symptomatic or asymptomatic episode \>30 seconds on an arrhythmia monitoring device between day 91 to 365 post the index procedure.

    Time frame: Up to 12 Months

06

Results

Posted Feb 10, 2020

Participant flow

Participant flow — Overall Study
MilestoneRoll-in Study Phase: RF AblationMain Study Phase: RF Ablation
Started890
Safety887
Completed887
Not completed03
Withdrew: Eligibility criteria not met03

Outcome measures

PrimaryNumber of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis

A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

Time frame:
Up to 90 days (post initial mapping and ablation procedure)
Reported as:
Count of participants · Participants
Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis
ParticipantsRadiofrequency (RF) Ablation
Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis0
PrimaryNumber of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding

A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

Time frame:
Up to 7 days (post initial mapping and ablation procedure)
Reported as:
Count of participants · Participants
Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding
ParticipantsRadiofrequency (RF) Ablation
Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding1
PrimaryPercentage of Participants With Acute Procedural Success

Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).

Time frame:
Day 1
Reported as:
Number · Percentage of participants
Percentage of Participants With Acute Procedural Success
Percentage of participantsRadiofrequency (RF) Ablation
Percentage of Participants With Acute Procedural Success100
SecondaryNumber of Participants With Individual PAE From Primary Composite

A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included death, atrio-esophageal fistula (AE fistula) and pulmonary vein stenosis (PVST); and up to 90 days post procedure which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

Time frame:
Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)
Reported as:
Count of participants · Participants
Number of Participants With Individual PAE From Primary Composite
ParticipantsRadiofrequency (RF) Ablation
Death0
Atrio-esophageal fistula0
Myocardial infraction0
Cardiac tamponade/perforation0
Thromboembolism0
Stroke/cerebrovascular accident (CVA)0
Transient ischemic attack0
Phrenic nerve paralysis0
Pulmonary vein stenosis0
Major vascular access complication/bleeding1
SecondaryNumber of Participants With Serious Adverse Device Effects (SADEs)

An adverse device effect is an adverse event related to the to the device and or the procedure of the investigational medical device. SADE is an adverse device effect that has resulted in any of the consequences characteristic of an SAE.

Time frame:
Up to 405 Days
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Device Effects (SADEs)
ParticipantsRadiofrequency (RF) Ablation
Number of Participants With Serious Adverse Device Effects (SADEs)1
SecondaryNumber of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure

Serious non-primary adverse event was defined as SAE that are not primary adverse events. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

Time frame:
Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
Reported as:
Count of participants · Participants
Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure
ParticipantsRadiofrequency (RF) Ablation
0 - 7 Days0
8 - 30 Days0
>= 31 Days1
SecondaryNumber of Participants With Non-serious Adverse Events

An AE is any untoward medical occurrence in participants whether or not related to the investigational medical device.

Time frame:
Up to 405 Days
Reported as:
Count of participants · Participants
Number of Participants With Non-serious Adverse Events
ParticipantsRadiofrequency (RF) Ablation
Number of Participants With Non-serious Adverse Events46
SecondaryNumber of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli

Number of participants with pre-and post-ablation asymptomatic and symptomatic cerebral emboli was reported.

Time frame:
Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)
Reported as:
Count of participants · Participants
Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli
ParticipantsRadiofrequency (RF) Ablation
Pre-procedure0
Discharge3
1 Month0
Unscheduled visit0
SecondaryNumber of Participants With Symptomatic and Asymptomatic Cerebral Emboli

Number of participants with symptomatic and asymptomatic cerebral emboli was reported

Time frame:
Up to 405 Days
Reported as:
Count of participants · Participants
Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli
ParticipantsRadiofrequency (RF) Ablation
Symptomatic0
Asymptomatic4
SecondaryNumber of Participants With New or Worsening Neurologic Deficits

Number of participants with new or worsening neurologic deficits was reported.

Time frame:
Pre-procedure, discharge, 1 Month, 3 Month and 6 Month
Reported as:
Count of participants · Participants
Number of Participants With New or Worsening Neurologic Deficits
ParticipantsRadiofrequency (RF) Ablation
Pre-procedure0
Discharge1
1 Month0
3 Month0
6 Month0
SecondaryNumber of Participants With NIHSS Scores

The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed to calculate a patient's total NIHSS score. The patient's total NIHSS score ranges from 0 (minimum) - 42 (maximum). Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke).

Time frame:
Pre-procedure and at discharge (Up to 405 Days)
Reported as:
Count of participants · Participants
Number of Participants With NIHSS Scores
ParticipantsRadiofrequency (RF) Ablation
Pre-procedure: NIHSS Score: 031
Pre-procedure: NIHSS Score: 1-40
Pre-procedure: NIHSS Score: 5-150
Pre-procedure: NIHSS Score: 16-200
Pre-procedure: NIHSS Score: 21-420
Discharge: NIHSS Score: 031
Discharge: NIHSS Score: 1-40
Discharge: NIHSS Score: 5-150
Discharge: NIHSS Score: 16-200
Discharge: NIHSS Score: 21-420
SecondaryNumber of Participants With MoCA Scores

Montreal Cognitive Assessment (MoCA) is used for detecting cognitive impairment, the scores range from 0 to 30. A score of 26 or higher is considered normal, patients with mild cognitive impairment (MCI) were scored an average of 22 and patients with significant cognitive impairment (SCI) were scored an average of 16.

Time frame:
Up to 405 Days
Reported as:
Count of participants · Participants
Number of Participants With MoCA Scores
ParticipantsRadiofrequency (RF) Ablation
Pre-procedure: 0-2516
Pre-procedure: 26-3015
1 Month: 0-256
1 Month: 26-3024
3 Month: 0-251
3 Month: 26-301
6 Month: 0-251
6 Month: 26-300
SecondaryNumber of Participants With Hospitalization for Cardiovascular Events

Hospitalization was defined as prolonged stay greater than or equal to (\>=) 2 nights post index procedure or in-patient stay not concurrent with index procedure \>= 1 calendar day. Hospitalization included cardiovascular events due to any cause post index procedure, regardless of protocol-defined serious/non-serious adverse events (AEs) or not. Hence this data was not contributed in serious Adverse events until met the AE definition.

Time frame:
Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)
Reported as:
Count of participants · Participants
Number of Participants With Hospitalization for Cardiovascular Events
ParticipantsRadiofrequency (RF) Ablation
0 - 7 Days2
8 - 30 Days0
>= 31 Days5
SecondaryPercentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants

Percentage of participants with PVI touch-up by balloon and/or focal catheter among all targeted veins and by participants was reported. Most of the participants were ablated by Balloon catheter only while one participant was ablated with both Balloon and Focal catheters.

Time frame:
Up to 405 Days
Reported as:
Number · Percentage of participants
Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants
Percentage of participantsRadiofrequency (RF) Ablation
Balloon Catheter Ablation: Left Superior Pulmonary Vein (LSPV)100.0
Balloon Catheter Ablation: Left Inferior Pulmonary Vein (LIPV)100.0
Balloon Catheter Ablation: Right Superior Pulmonary Vein (RSPV)100.0
Balloon Catheter Ablation: Right Inferior Pulmonary Vein (RIPV)98.8
Balloon Catheter Ablation: Right Middle Pulmonary Vein (RMPV)100.0
Balloon Catheter Ablation: Left Pulmonary Vein (LPV)-common100.0
Balloon and Focal Catheter Ablation: LSPV0.0
Balloon and Focal Catheter Ablation: LIPV0.0
Balloon and Focal Catheter Ablation: RSPV0.0
Balloon and Focal Catheter Ablation: RIPV1
Balloon and Focal Catheter Ablation: RMPV0.0
Balloon and Focal Catheter Ablation: LPV-common0.0
SecondaryPercentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers

Percentage of participants with use of focal catheter ablation for non-PV triggers was reported.

Time frame:
Up to 405 Days
Reported as:
Number · Percentage of participants
Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers
Percentage of participantsRadiofrequency (RF) Ablation
Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers3.5
SecondaryPercentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL

Percentage of participants with six-month arrythmia recurrence \[defined as freedom from documented symptomatic or asymptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atypical (left side) atrial flutter (AFL) episodes (episodes \>30 seconds on arrhythmia monitoring device from Day 91 to 180 post the index procedure)\] was reported.

Time frame:
Up to 6 Months
Reported as:
Number · Percentage of participants
Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL
Percentage of participantsRadiofrequency (RF) Ablation
Documented AF/AT/AFL76.2
Documented Symptomatic AF/AT/AFL81.0
SecondaryPercentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL

Twelve-month Arrythmia recurrence is defined as a documented symptomatic or asymptomatic episode \>30 seconds on an arrhythmia monitoring device between day 91 to 365 post the index procedure.

Time frame:
Up to 12 Months
Reported as:
Number · Percentage of participants
Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL
Percentage of participantsRadiofrequency (RF) Ablation
Documented AF/AT/AFL65.8
Documented Symptomatic AF/AT/AFL72.2

Adverse events

Collected over Up to 405 Days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Roll-in Study Phase: RF Ablation0/8 (0%)1/8 (12.5%)0/8 (0%)
Main Study Phase: RF Ablation0/87 (0%)2/87 (2.3%)0/87 (0%)
Most frequent serious events
Most frequent serious events
EventRoll-in Study Phase: RF AblationMain Study Phase: RF Ablation
ST-elevation myocardial infarctionCardiac disorders1/80/87
Major Vascular Access Complication/ BleedingCardiac disorders0/81/87
SyncopeNervous system disorders0/81/87
Lumbar vertebral fractureInjury, poisoning and procedural complications0/81/87
Sternal fractureInjury, poisoning and procedural complications0/81/87

Baseline characteristics

Safety Population included all enrolled participants who have undergone insertion of the study catheter.

Age, Continuous
Age, Continuous(Years)Roll-in Study Phase: Radiofrequency (RF) AblationMain Study Phase: RF AblationTotal
Mean61.9 ± 6.9060.2 ± 10.0560.3 ± 9.81
Sex: Female, Male
Sex: Female, Male(Participants)Roll-in Study Phase: Radiofrequency (RF) AblationMain Study Phase: RF AblationTotal
Female33134
Male55661
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Roll-in Study Phase: Radiofrequency (RF) AblationMain Study Phase: RF AblationTotal
Count of participants——0
07

Study locations

5 sites
  • Na Homolce Hospital
    Prague, Czechia
  • Ospedale "F. Miulli"
    Bari, Italy
  • Centro Cardiologico Monzino
    Milan, Italy
  • Liverpool Heart and Chest Hospital
    Liverpool, United Kingdom
  • Bart's Health NHS Trust
    London, United Kingdom
08

References and documents

Publications

  • Schilling R, Dhillon GS, Tondo C, Riva S, Grimaldi M, Quadrini F, Neuzil P, Chierchia GB, de Asmundis C, Abdelaal A, Vanderlinden L, Tan T, Ding WY, Gupta D, Reddy VY. Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE. Europace. 2021 Jun 7;23(6):851-860. doi: 10.1093/europace/euaa382. PubMed 33450010 ↗

Study documents

  • Study protocol · Jul 20, 2018
  • Statistical analysis plan · Oct 2, 2018

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03437733
Lead sponsor
Biosense Webster, Inc.
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Feb 28, 2018
Primary completion
Feb 1, 2019
Completion
Oct 17, 2019
Results posted
Feb 10, 2020
Last update
Jun 29, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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