CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 156 enrolled
Drug / intervention
TactiCath SEdevice
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/NCT03354663
NCT03354663N/ACompleted
CompareCT.gov

Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation

Abbott Medical Devices·interventional·Posted Nov 28, 2017·Updated Oct 11, 2023

In Brief

A clinical study evaluating TactiCath SE for Paroxysmal Atrial Fibrillation. Completed, enrolled 156 participants across 21 sites in 4 countries.

Detailed Summary

This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). 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 in the United States. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. This clinical investigation is sponsored by Abbott.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesAustralia, Germany, Italy, United States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 28, 2017
Enrollment StartDec 11, 2017
Primary CompletionAug 2, 2018
Study CompletionOct 30, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.6 years ago

Interventions

TactiCath SEdevice

Ablation to achieve pulmonary vein isolation.