CompletedNot Applicable

Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)

51 participantsStarted 2016-09-01

Plain-language summary

The QDOT-Micro 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
✓. Patients who have signed the Patient Informed Consent Form (ICF)
✓. Subjects diagnosed with symptomatic documented PAF\* who are candidates for catheter ablation
✓. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (eg. Patient not confined by a court ruling)

✕. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
✕. Previous ablation for atrial fibrillation.
✕. Previously diagnosed with persistent AF.
✕. Documented Left Atrial thrombus
✕. Any carotid stenting or endarterectomy
✕. LA size \>50mm
✕. LVEF \<40%
✕. Uncontrolled heart failure or NYHA function class III and IV

Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population

Timeframe: Day of ablation procedure

NCT IDNCT02944968

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-08-06

Results submitted2019-08-05