HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)

Phase 3

Completed

Conditions: Paroxysmal Atrial Fibrillation

Interventions: Procedure: Control Arm Ablation
Device: EAS-AC (HeartLight)

Registration Number: NCT01456000

Lead Sponsor: CardioFocus

Brief Summary: The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.

Detailed Description: A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 405

Inclusion Criteria

18 to 75 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm Ablation	Control Arm Ablation	Treatment with standard ablation.
EAS-AC (HeartLight)	EAS-AC (HeartLight)	Treatment with the EAS-AC.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description	1 year	Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (21): Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Prairie Heart Institute
🇺🇸
Springfield, Illinois, United States
Mayo Clinic Jacksonville
🇺🇸
Jacksonville, Florida, United States
University of Alabama, Birmingham
🇺🇸
Birminham, Alabama, United States
Pacific Heart Institute
🇺🇸
Santa Monica, California, United States
Stanford Hospital
🇺🇸
Palo Alto, California, United States
Regional Cardiology Associates, Mercy General Hospital
🇺🇸
Sacramento, California, United States
UCSF
🇺🇸
San Francisco, California, United States
Mt. Sinai Hospital
🇺🇸
NY, New York, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Methodist Hospital
🇺🇸
Houston, Texas, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸
Austin, Texas, United States
University of Virginia Health System
🇺🇸
Charlottesville, Virginia, United States
Sentara Cardiovascular Research Institute
🇺🇸
Norfolk, Virginia, United States
Mayo Clinic Rochester/St. Mary's Hospital
🇺🇸
Rochester, Minnesota, United States
The University of Kansas Medical Center
🇺🇸
Kansas City, Kansas, United States
Johns Hopkins
🇺🇸
Baltimore, Maryland, United States
Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Medical University South Carolina
🇺🇸
Charleston, South Carolina, United States
Intermountain Medical Center
🇺🇸
Murray, Utah, United States
Duke University
🇺🇸
Durham, North Carolina, United States