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

Biosense Webster

Status and phase: Completed; Phase 3

Conditions: Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Treatments: Device: THERMOCOOL® SMARTTOUCH™ Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01639495

SMART-AF CA

Details and patient eligibility

About

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

Full description

The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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148 participants in 1 patient group

THERMOCOOL® SMARTTOUCH™ Catheter

Experimental group

Treatment:

Device: THERMOCOOL® SMARTTOUCH™ Catheter