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CompletedNCT01056328IRASE-AFUpdated Feb 26, 2019Results posted

Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

An interventional study of SJM Irrigated Cardiac Ablation System and FDA approved Open Irrigated RF Ablation System in Paroxysmal Atrial Fibrillation, sponsored by Abbott Medical Devices. Completed at 30 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
324
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.

02

Conditions studied

  • Paroxysmal Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 324 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.

Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.

Browse Abbott Medical Devices studies →All Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older
  • Signed Patient Informed Consent Form
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements
  • Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation* [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation*, or intolerable side effects due to AAD

  • Subjects with symptomatic paroxysmal atrial fibrillation (PAF)*

    • PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.

Exclusion criteria

Exclusion Criteria:

  • Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Previous ablation for AF
  • History of any valvular cardiac surgical procedure
  • Coronary artery bypass grafting (CABG) procedure within the last six months
  • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
  • Left atrial thrombus
  • History of a documented thromboembolic event within the past one (1) year
  • Diagnosed atrial myxoma
  • An implanted implantable cardioverter defibrillator (ICD)
  • 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
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
  • Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable)
  • Acute illness or active systemic infection or sepsis
  • Unstable angina
  • Myocardial infarction within the previous two months
  • Left ventricular ejection fraction (LVEF) \<40% as determined by pre-procedure transthoracic echocardiogram (TTE)
  • History of blood clotting or bleeding abnormalities
  • Contraindication to anticoagulation (i.e. heparin or warfarin)
  • Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure
  • Life expectancy less than 12 months
  • Enrollment in an investigational study evaluating another device or drug
  • Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure
  • An intramural thrombus tumor, or other abnormality that precludes catheter introduction or manipulation
  • Presence of a condition that precludes vascular access
  • Left atrial size ≥ 50 mm as determined by pre-procedure TTE
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
324 participants (actual)

Study arms

  • Experimental
    St. Jude Medical Cardiac Ablation System

    Device: SJM Irrigated Cardiac Ablation System

  • Active comparator
    FDA approved Open Irrigated Radio Frequency Ablation System

    Device: FDA approved Open Irrigated RF Ablation System

Interventions

  • DeviceSJM Irrigated Cardiac Ablation System

    Irrigated ablation catheter

  • DeviceFDA approved Open Irrigated RF Ablation System

    Irrigated ablation catheter

06

What researchers measure

Primary outcomes

  1. Confirmation of Entrance Block in the Pulmonary Veins

    Time frame: 20 minutes after initial isolation

  2. Incidence of Adverse Events Included in the Pre-specified Composite

    Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.

    Time frame: 7 days

  3. Incidence of Adverse Events Included in the Pre-specified Composite.

    Time frame: 12 months

Secondary outcomes

  1. Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period

    Time frame: 12 months

  2. Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs

    Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)

    Time frame: 12 months

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Results

Posted May 23, 2014

Participant flow

Participant flow — Overall Study
MilestoneSJM Cardiac Ablation SystemFDA Approved Open Irriagated RF Ablation System
Started164160
Completed147144
Not completed1716

Outcome measures

PrimaryConfirmation of Entrance Block in the Pulmonary Veins
Time frame:
20 minutes after initial isolation
Reported as:
Number · participants
Confirmation of Entrance Block in the Pulmonary Veins
participantsSJM Cardiac Ablation SystemFDA Approved Open Irriagated RF Ablation System
Confirmation of Entrance Block in the Pulmonary Veins159157
PrimaryIncidence of Adverse Events Included in the Pre-specified Composite

Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.

Time frame:
7 days
Reported as:
Number · participants
Incidence of Adverse Events Included in the Pre-specified Composite
participantsSt Jude Medical (SJM) Cardiac Ablation SystemFDA Approved Open Irrigated RF Ablation System
Incidence of Adverse Events Included in the Pre-specified Composite76
PrimaryIncidence of Adverse Events Included in the Pre-specified Composite.
Time frame:
12 months
Reported as:
Number · participants
Incidence of Adverse Events Included in the Pre-specified Composite.
participantsSJM Cardiac Ablation SystemFDA Approved Open Irriagated RF Ablation System
Incidence of Adverse Events Included in the Pre-specified Composite.1213
SecondaryDocumented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
Time frame:
12 months
Reported as:
Number · participants
Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
participantsSJM Cardiac Ablation SystemFDA Approved Open Irrigated RF Ablation System
Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period116119
SecondaryEarly Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs

Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)

Time frame:
12 months
Reported as:
Number · participants
Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs
participantsSJM Cardiac Ablation SystemFDA Approved Open Irriagated RF Ablation System
Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs4026

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SJM Cardiac Ablation System—26/164 (15.9%)14/164 (8.5%)
FDA Approved Open Irrigated RF Ablation System—16/160 (10%)10/160 (6.3%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventSJM Cardiac Ablation SystemFDA Approved Open Irrigated RF Ablation System
OtherGeneral disorders8/1646/160
Pulmonary vein stenosisCardiac disorders5/1647/160
Coronary artery spasmCardiac disorders0/1642/160
HypotensionCardiac disorders2/1640/160
Pericardial effusionCardiac disorders2/1640/160
Pulmonary edemaRespiratory, thoracic and mediastinal disorders2/1640/160
ArrhythmiaCardiac disorders2/1640/160
Cardiac perforationCardiac disorders1/1641/160
PericarditisCardiac disorders0/1641/160
Chest and back painMusculoskeletal and connective tissue disorders1/1640/160
Most frequent other events
Most frequent other events
EventSJM Cardiac Ablation SystemFDA Approved Open Irrigated RF Ablation System
OtherGeneral disorders6/1644/160
Local hematomaVascular disorders3/1642/160
InfectionInfections and infestations2/1640/160
Chest and back painMusculoskeletal and connective tissue disorders1/1641/160
HypotensionCardiac disorders1/1641/160
PseudoaneurysmVascular disorders0/1641/160
Skin burnSkin and subcutaneous tissue disorders0/1641/160
PericarditisCardiac disorders1/1640/160

Baseline characteristics

Age, Continuous
Age, Continuous(years)SJM Cardiac Ablation SystemFDA Approved Open Irriagated RF Ablation SystemTotal
Mean58.5 ± 12.460.6 ± 9.759.5 ± 11.2
Age, Categorical
Age, Categorical(Participants)SJM Cardiac Ablation SystemFDA Approved Open Irriagated RF Ablation SystemTotal
<=18 years000
Between 18 and 65 years9696192
>=65 years6864132
Sex: Female, Male
Sex: Female, Male(Participants)SJM Cardiac Ablation SystemFDA Approved Open Irriagated RF Ablation SystemTotal
Female5966125
Male10594199
Region of Enrollment
Region of Enrollment(participants)SJM Cardiac Ablation SystemFDA Approved Open Irriagated RF Ablation SystemTotal
United States149149298
Korea, Republic of9716
Canada6410
08

Study locations

30 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • Arizona Arrhythmia Consultants/Scottsdale Healthcare
    Scottsdale, Arizona 85251, United States
  • Good Samaritan Hospital
    Los Angeles, California 90017, United States
  • University of Californai, San Diego Medical Center
    San Diego, California 92037, United States
  • Colorado Cardiac Alliance
    Colorado Springs, Colorado 80907, United States
  • Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center
    Jacksonville, Florida 32204, United States
  • Tampa General Hospital
    Tampa, Florida 33606, United States
  • Emory University Hospital, Midtown
    Emory, Georgia 30308, United States
  • University of Kansas Hospital
    Kansas City, Kansas 66160, United States
  • Washington Adventist Hospital
    Takoma Park, Maryland 20912, United States
  • Spectrum Health
    Grand Rapids, Michigan 49503, United States
  • MAHI, Saint Luke's Hospital
    Kansas City, Missouri 64111, United States
  • NYU Langone Medical Center
    New York, New York 10016, United States
  • Mount Sinai Hospital
    New York, New York 10029, United States
  • University of Rochester
    Rochester, New York 14642, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • The Ohio State University Medical Center
    Columbus, Ohio 43210, United States
  • Doylestown Hospital
    Doylestown, Pennsylvania 18901, United States
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Centennial Medical Center
    Nashville, Tennessee 37203, United States
  • Texas Cardiac Arrhythmia Research Foundation
    Austin, Texas 78746, United States
  • Baylor Heart & Vascular Hospital
    Dallas, Texas 75226, United States
  • The Methodist Hospital Research Institute
    Houston, Texas 77030, United States
  • Intermountain Medical Center
    Salt Lake City, Utah 84157, United States
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
  • Inova Fairfax Hospital / Inova Heart and Vascular Institute
    Falls Church, Virginia 22042, United States
  • Sunybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
  • Severance Hospital
    Seoul, 120-752, South Korea
  • Korea University Anam Hospital
    Seoul, 136-705, South Korea
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01056328
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Jan 26, 2010
Start date
Feb 2010
Primary completion
Jan 2013
Completion
Jan 2013
Results posted
May 23, 2014
Last update
Feb 26, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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