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
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
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.
Exclusion Criteria:
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
radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode
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
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
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.
| Milestone | THERMOCOOL SMARTTOUCH SF-5D Catheter |
|---|---|
| Started | 54 |
| Completed | 52 |
| Not completed | 2 |
| Withdrew: Subject didn't receive study catheter | 2 |
Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.
| Participants | THERMOCOOL SMARTTOUCH SF-5D Catheter |
|---|---|
| Number of Subjects Achieved Acute Procedural Success | 52 |
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.
| Participants | THERMOCOOL SMARTTOUCH SF-5D Catheter |
|---|---|
| Incidence of Acute Safety | 2 |
Collected over 3 months post-procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| THERMOCOOL SMARTTOUCH SF-5D Catheter | 0/52 (0%) | 4/52 (7.7%) | 32/52 (61.5%) |
| Event | THERMOCOOL SMARTTOUCH SF-5D Catheter |
|---|---|
| Oesophageal ulcer haemorrhageGastrointestinal disorders | 1/52 |
| Vascular pseudoaneurysmInjury, poisoning and procedural complications | 1/52 |
| Atrial flutterCardiac disorders | 1/52 |
| SyncopeNervous system disorders | 1/52 |
| Event | THERMOCOOL SMARTTOUCH SF-5D Catheter |
|---|---|
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 6/52 |
| Cerebral ischaemiaNervous system disorders | 6/52 |
| HaematomaVascular disorders | 5/52 |
| Erosive oesophagitisGastrointestinal disorders | 3/52 |
| HeadacheNervous system disorders | 3/52 |
| Hiatus herniaGastrointestinal disorders | 2/52 |
| Atrioventricular block first degreeCardiac disorders | 1/52 |
| Bundle branch block leftCardiac disorders | 1/52 |
| Pericardial effusionCardiac disorders | 1/52 |
| Sinus bradycardiaCardiac disorders | 1/52 |
| Age, Continuous(Years) | THERMOCOOL SMARTTOUCH SF-5D Catheter |
|---|---|
| Mean | 62.0 ± 12.01 |
| Sex: Female, Male(Participants) | THERMOCOOL SMARTTOUCH SF-5D Catheter |
|---|---|
| Female | 18 |
| Male | 36 |
| Race and Ethnicity Not Collected(Participants) | THERMOCOOL SMARTTOUCH SF-5D Catheter |
|---|
| Region of Enrollment(Participants) | THERMOCOOL SMARTTOUCH SF-5D Catheter |
|---|---|
| European Union | 54 |
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Biosense Webster, Inc.