CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
THERMOCOOL® SMARTTOUCH™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/NCT02485925
NCT02485925Phase 4Completed
CompareCT.gov

The Effectiveness and Safety in the Treatment of Circumferential Pulmonary Vein Isolation (CPVI) for Symptomatic Paroxysmal Atrial Fibrillation With THERMOCOOL® SMARTTOUCH™ Catheter in China, A Multi-center Clinical Registry Study

Biosense Webster, Inc.·interventional·Posted Jun 30, 2015·Updated Feb 4, 2025

In Brief

A Phase 4 clinical trial evaluating THERMOCOOL® SMARTTOUCH™ for Atrial Fibrillation. Completed, enrolled 200 participants.

Detailed Summary

This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 30, 2015
Enrollment StartJul 1, 2015
Primary CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.0 years ago

Interventions

THERMOCOOL® SMARTTOUCH™device

Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)