HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)

Phase 3

Completed

• Conditions: Paroxysmal Atrial Fibrillation

• 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.

Study Timeline

• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Study Start: 2012-01
• Primary Completion: 2014-12
• Disposition First Submitted: 2015-05-27
• Disposition First Submitted QC: 2015-07-30
• Disposition First Posted: 2015-08-20
• Study Completion: 2016-01
• Results First Submitted: 2016-04-18
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Results First Posted: 2016-09-08
• Last Update Posted: 2016-09-08

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

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.

Trial Locations

Locations (21)

University of Alabama, Birmingham; 🇺🇸 Birminham, Alabama, 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

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

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Prairie Heart Institute; 🇺🇸 Springfield, Illinois, United States

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

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