NCT01385202

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT01385202

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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.

Eligibility

Inclusion Criteria:

* Have had at least 3 atrial fibrillation episodes within 6 months of this study
* Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
* 18 years of age or older

Exclusion Criteria:

* Have had previous ablation for atrial fibrillation
* Have take amiodarone within 6 months of this study
* Have had any heart surgery within the last 60 days
* Have had a heart attack within the last 60 days
* Females who are pregnant or breast feeding

Disease(s) and\or Condition(s)

Heart Diseases

Arrhythmia

Atrial Fibrillation

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DEVICE
- Name: THERMOCOOL® SMARTTOUCH™ Catheter
- Description: AF Ablation
- Arm Group Labels: THERMOCOOL® SMARTTOUCH™ Catheter

Sponsor

Biosense Webster, Inc.