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

Biosense Webster, Inc.148 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Interventions

THERMOCOOL® SMARTTOUCH™ CatheterDEVICE

AF Ablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

University of Alabama, Birmingham

Birmingham, Alabama, United States

Stanford University School of Medicine

Outcomes

Primary Outcomes

Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias

Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures

Time frame: Day 91-361

Incidence of Primary Adverse Events Within Specified Study Period

Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.

Time frame: 12 months post procedure

Secondary Outcomes

Peri-procedural Serious Adverse Events

Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure

Time frame: Within 8-30 days post procedure

Percentage of Subjects Achieved Acute Effectiveness

Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins

Time frame: 5 hours of procedure time

Late Onset Serious Adverse Events

Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure

Data from ClinicalTrials.gov

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