CompletedNot Applicable

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.

Austria, Belgium, Czechia54 participantsStarted 2018-04-02

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
✕. Previous surgical or catheter ablation for atrial fibrillation.
✕. Previously diagnosed with persistent, longstanding AF and/or continuous AF \>7 days, or \>48 hrs. terminated by cardioversion.
✕. Documented Left Atrial thrombus on baseline/pre-procedure imaging.
✕. Any carotid stenting or endarterectomy.
✕. Left atrial (LA) size \>50mm.
✕. Left Ventricular ejection fraction (LVEF) \<40%.
✕. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.

Number of Subjects Achieved Acute Procedural Success

Timeframe: Day 1

Incidence of Acute Safety

Timeframe: 7 days post-procedure

NCT IDNCT03459196

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-08

Results submitted2019-09-20