MedTrace Logo

THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

NCT01385202 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-02-04

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DEVICE

THERMOCOOL® SMARTTOUCH™ Catheter

AF Ablation

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrea Natale, MD · Texas Cardiac Arrhythmia Research

  • David J Wilber, MD · Loyola University

  • Francis E Marchlinski, MD · University of Pennsylvania

  • Douglas L Packer, MD · Mayo Clinic

  • Hiroshi Nakagawa, MD, Ph.D. · University of Oklahoma

  • Hans Kottkamp, MD · University Leipzig

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-02-28
Completion
2013-05-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01385202 on ClinicalTrials.gov