CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 224 enrolled
Drug / intervention
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™device
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/NCT03650556
NCT03650556N/ACompleted
CompareCT.gov

Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)

Abbott Medical Devices·interventional·Posted Aug 28, 2018·Updated Apr 27, 2022

In Brief

A clinical study evaluating TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ for Persistent Atrial Fibrillation. Completed, enrolled 224 participants across 22 sites in 2 countries.

Detailed Summary

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent Atrial Fibrillation
CountriesAustralia, United States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 28, 2018
Enrollment StartSep 28, 2018
Primary CompletionDec 21, 2020
Study CompletionJan 11, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.8 years ago

Interventions

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™device

Ablation procedure for Persistent AF