Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Phase 2

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: CardioFocus HeartLight Endoscopic Ablation System

• Registration Number: NCT00971204
• Lead Sponsor: CardioFocus

Brief Summary

This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Primary Completion: 2011-12
• Study Completion: 2012-06
• Results First Submitted: 2016-04-18
• Results First Submitted QC: 2016-06-16
• Status Verified: 2016-07
• Results First Posted: 2016-07-27
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 18 to 70 years
• paroxysmal atrial fibrillation
• failure of at least one AAD
• others

Exclusion Criteria

• overall good health as established by multiple criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with HeartLight System	CardioFocus HeartLight Endoscopic Ablation System	Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System

Primary Outcome Measures

Name	Time	Method
Freedom From Recurrence of Atrial Fibrillation	12 months	Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.

Trial Locations

Locations (10)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States

The Methodist Hospital Research Institute; 🇺🇸 Houston, Texas, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

Pacific Heart Institute; 🇺🇸 Santa Monica, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mt. Sinai Hospital; 🇺🇸 New York, New York, United States

University Of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States