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

Biosense Webster

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation; Arrhythmia; Heart Diseases

Treatments: Device: THERMOCOOL® SMARTTOUCH™ Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01385202

Smart-AF

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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172 participants in 1 patient group

THERMOCOOL® SMARTTOUCH™ Catheter

Experimental group

Treatment:

Device: THERMOCOOL® SMARTTOUCH™ Catheter