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CompletedNCT03459196QDOT-FASTUpdated Jun 29, 2025Results posted

Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.

An interventional study of THERMOCOOL SMARTTOUCH SF-5D Catheter in Paroxysmal Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Completed at 7 sites in 4 countries. Open to participants aged 18 Years and older. 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
54
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.

Read the detailed description

The purpose of this study is to evaluate safety and acute performance of the THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode in the treatment of Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.

The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.

02

Conditions studied

  • Paroxysmal Atrial Fibrillation

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Keywords

  • Interventional
  • Radiofrequency Ablation
  • Paroxysmal Atrial Fibrillation
03

Who can participate

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

Inclusion criteria

  1. Age 18 or older.
  2. Signed the Patient Informed Consent Form (ICF).
  3. Diagnosed with symptomatic PAF
  4. Selected for catheter ablation through pulmonary vein isolation.
  5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patient not confined by a court ruling).

Exclusion criteria

Exclusion Criteria:

  1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  2. Previous surgical or catheter ablation for atrial fibrillation.
  3. Previously diagnosed with persistent, longstanding AF and/or continuous AF >7 days, or >48 hrs. terminated by cardioversion.
  4. Documented Left Atrial thrombus on baseline/pre-procedure imaging.
  5. Any carotid stenting or endarterectomy.
  6. Left atrial (LA) size >50mm.
  7. Left Ventricular ejection fraction (LVEF) \<40%.
  8. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
  9. History of blood clotting or bleeding abnormalities
  10. Contraindication to anticoagulation
  11. History of a documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months.
  12. Previous percutaneous coronary intervention (PCI) or myocardial Infarction (MI) within the past 2 months.
  13. Coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (e.g. ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure.
  14. Rheumatic Heart Disease
  15. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
  16. Unstable angina.
  17. Significant pulmonary disease (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other diseaseor malfunction of the lungs or respiratory system that produces chronic symptoms.
  18. Acute illness, active systemic infection, or sepsis.
  19. Presence of atrial myxoma, interatrial baffle or patch
  20. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
  21. Presence of a condition that precludes vascular access.
  22. Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD).
  23. Presence of IVC filter
  24. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
  25. Currently enrolled in an investigational study evaluating another device, biologic, or drug.
  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. Life expectancy or other disease processes likely to limit survival to less than 12 months.
  28. Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.
  29. Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
  30. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
  31. Presence of iron-containing metal fragments in the body
  32. 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
54 participants (actual)

Study arms

  • Experimental
    Treatment Group

    A novel radiofrequency ablation catheter combining microelectrodes, thermocouples, porous tip irrigation and contact force sensing nMARQ Multi-Channel RF Generator with Software including TGA mode (Temperature Guided Ablation).

    Device: THERMOCOOL SMARTTOUCH SF-5D Catheter

Interventions

  • DeviceTHERMOCOOL SMARTTOUCH SF-5D Catheter

    radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode

05

What researchers measure

Primary outcomes

  1. Number of Subjects Achieved Acute Procedural Success

    Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.

    Time frame: Day 1

  2. Incidence of Acute Safety

    Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs.

    Time frame: 7 days post-procedure

06

Results

Posted Nov 6, 2019

Participant flow

A total of 54 subjects were enrolled in the study at 7 sites in Europe. The first subject was enrolled on April 17th, 2018 and the last subject was enrolled on June 20th, 2018.

Participant flow — Overall Study
MilestoneTHERMOCOOL SMARTTOUCH SF-5D Catheter
Started54
Completed52
Not completed2
Withdrew: Subject didn't receive study catheter2

Outcome measures

PrimaryNumber of Subjects Achieved Acute Procedural Success

Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.

Time frame:
Day 1
Reported as:
Count of participants · Participants
Number of Subjects Achieved Acute Procedural Success
ParticipantsTHERMOCOOL SMARTTOUCH SF-5D Catheter
Number of Subjects Achieved Acute Procedural Success52
PrimaryIncidence of Acute Safety

Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs.

Time frame:
7 days post-procedure
Reported as:
Count of participants · Participants
Incidence of Acute Safety
ParticipantsTHERMOCOOL SMARTTOUCH SF-5D Catheter
Incidence of Acute Safety2

Adverse events

Collected over 3 months post-procedure. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
THERMOCOOL SMARTTOUCH SF-5D Catheter0/52 (0%)4/52 (7.7%)32/52 (61.5%)
Most frequent serious events
Most frequent serious events
EventTHERMOCOOL SMARTTOUCH SF-5D Catheter
Oesophageal ulcer haemorrhageGastrointestinal disorders1/52
Vascular pseudoaneurysmInjury, poisoning and procedural complications1/52
Atrial flutterCardiac disorders1/52
SyncopeNervous system disorders1/52
Most frequent other events
Showing 10 of 28
Most frequent other events
EventTHERMOCOOL SMARTTOUCH SF-5D Catheter
Gastrooesophageal reflux diseaseGastrointestinal disorders6/52
Cerebral ischaemiaNervous system disorders6/52
HaematomaVascular disorders5/52
Erosive oesophagitisGastrointestinal disorders3/52
HeadacheNervous system disorders3/52
Hiatus herniaGastrointestinal disorders2/52
Atrioventricular block first degreeCardiac disorders1/52
Bundle branch block leftCardiac disorders1/52
Pericardial effusionCardiac disorders1/52
Sinus bradycardiaCardiac disorders1/52

Baseline characteristics

Age, Continuous
Age, Continuous(Years)THERMOCOOL SMARTTOUCH SF-5D Catheter
Mean62.0 ± 12.01
Sex: Female, Male
Sex: Female, Male(Participants)THERMOCOOL SMARTTOUCH SF-5D Catheter
Female18
Male36
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)THERMOCOOL SMARTTOUCH SF-5D Catheter
Region of Enrollment
Region of Enrollment(Participants)THERMOCOOL SMARTTOUCH SF-5D Catheter
European Union54
07

Study locations

7 sites
  • Elisabethinen Hospital
    Linz, Austria
  • OLV Aalst
    Aalst, Belgium
  • AZ Sint-Jan
    Bruges, Belgium
  • Jessa Ziekenhuis
    Hasselt, Belgium
  • Ceské Budejovice Hospital
    České Budějovice, Czechia
  • Na Homolce
    Prague, Czechia
  • Ospedale F Miulli
    Bari, Italy
08

References and documents

Publications

  • Reddy VY, Grimaldi M, De Potter T, Vijgen JM, Bulava A, Duytschaever MF, Martinek M, Natale A, Knecht S, Neuzil P, Purerfellner H. Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial. JACC Clin Electrophysiol. 2019 Jul;5(7):778-786. doi: 10.1016/j.jacep.2019.04.009. Epub 2019 May 8. PubMed 31320006 ↗

Related links

Study documents

  • Study protocol · Dec 21, 2017
  • Statistical analysis plan · Nov 13, 2018

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

09

Registry details

Key details

Study ID
NCT03459196
Lead sponsor
Biosense Webster, Inc.
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
Apr 2, 2018
Primary completion
Oct 8, 2018
Completion
Oct 8, 2018
Results posted
Nov 6, 2019
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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