CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 165 enrolled
Drug / intervention
THERMOCOOL® SMARTTOUCH® (RF ablation treatment)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/NCT02359890
NCT02359890Phase 3Completed
CompareCT.gov

Prospective Safety Assessment of the THERMOCOOL® SMARTTOUCH® SF Family of Contact Force Sensing Catheters for the Radiofrequency Ablation Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Biosense Webster, Inc.·interventional·Posted Feb 10, 2015·Updated Feb 4, 2025

In Brief

A Phase 3 clinical trial evaluating THERMOCOOL® SMARTTOUCH® (RF ablation treatment) for Atrial Fibrillation. Completed, enrolled 165 participants.

Detailed Summary

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

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 10, 2015
Enrollment StartMar 1, 2015
Primary CompletionSep 1, 2015
Study CompletionNov 8, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.4 years ago

Interventions

THERMOCOOL® SMARTTOUCH® (RF ablation treatment)device

Radiofrequency Ablation Treatment