CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 355 enrolled
Drug / intervention
TactiFlex SE +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04356040
NCT04356040N/ACompleted
CompareCT.gov

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

Abbott Medical Devices·interventional·Posted Apr 21, 2020·Updated Oct 31, 2023

In Brief

A clinical study evaluating TactiFlex SE and TactiFlex SE - High Standard Power for Paroxysmal Atrial Fibrillation. Completed, enrolled 355 participants across 45 sites in 10 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesAustralia, Austria, Canada, Czechia, Germany, Hong Kong, Italy, Netherlands, Taiwan, United States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 21, 2020
Enrollment StartJun 29, 2020
Primary CompletionJul 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.2 years ago

Interventions

TactiFlex SEdevice

Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.

TactiFlex SE - High Standard Powerdevice

Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.