NCT01639495

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT01639495

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

Summary

This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.

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 including, but not limited to:

* 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)

Drug Refractory Symptomatic Paroxysmal 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.