TactiFlex Paroxysmal Atrial Fibrillation IDE Trial

Trial ID or NCT#

NCT04356040

Status

not recruiting iconNOT RECRUITING

Purpose

Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).

Official Title

Safety and Effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for Treating Drug-refractory, Symptomatic Atrial Fibrillation.

Eligibility Criteria

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Exclusion Criteria:
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Investigator(s)

Tina Baykaner
Assistant Professor of Medicine (Cardiovascular Medicine)

View on ClinicalTrials.gov