CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 172 enrolled
Drug / intervention
THERMOCOOL® SMARTTOUCH™ Catheterdevice
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/NCT01385202
NCT01385202Phase 3Completed
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THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

Biosense Webster, Inc.·interventional·Posted Jun 30, 2011·Updated Feb 4, 2025

In Brief

A Phase 3 clinical trial evaluating THERMOCOOL® SMARTTOUCH™ Catheter for Heart Diseases and 2 related conditions. Completed, enrolled 172 participants.

Detailed Summary

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Diseases, Arrhythmia, Atrial Fibrillation
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2011
Enrollment StartJun 1, 2011
Primary CompletionFeb 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.0 years ago

Interventions

THERMOCOOL® SMARTTOUCH™ Catheterdevice

AF Ablation