HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
HeartLight
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation
1 other identifier
interventional
405
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2012
Typical duration for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
September 8, 2016
CompletedSeptember 8, 2016
July 1, 2016
2.9 years
October 17, 2011
April 18, 2016
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description
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.
1 year
Study Arms (2)
EAS-AC (HeartLight)
EXPERIMENTALTreatment with the EAS-AC.
Control Arm Ablation
ACTIVE COMPARATORTreatment with standard ablation.
Interventions
Eligibility Criteria
You may qualify if:
- to 75 years.
- paroxysmal atrial fibrillation
- failure of at least one AAD
- others
You may not qualify if:
- overall good health as established by multiple criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioFocuslead
Study Sites (21)
University of Alabama, Birmingham
Birminham, Alabama, United States
Stanford Hospital
Palo Alto, California, 94305, United States
Regional Cardiology Associates, Mercy General Hospital
Sacramento, California, 95819, United States
UCSF
San Francisco, California, 94143, United States
Pacific Heart Institute
Santa Monica, California, 90404, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224-1865, United States
Prairie Heart Institute
Springfield, Illinois, 62701, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beaumont Hospital
Royal Oak, Michigan, 48072, United States
Mayo Clinic Rochester/St. Mary's Hospital
Rochester, Minnesota, 55902, United States
Mt. Sinai Hospital
New York, New York, 10029, United States
Duke University
Durham, North Carolina, 27710, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University South Carolina
Charleston, South Carolina, 29425, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Methodist Hospital
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
Related Publications (1)
Dukkipati SR, Cuoco F, Kutinsky I, Aryana A, Bahnson TD, Lakkireddy D, Woollett I, Issa ZF, Natale A, Reddy VY; HeartLight Study Investigators. Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation. J Am Coll Cardiol. 2015 Sep 22;66(12):1350-60. doi: 10.1016/j.jacc.2015.07.036.
PMID: 26383722DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Burke Barrett, VP Regulatory & Clinical Affairs
- Organization
- CardioFocus, Inc.
Study Officials
- STUDY DIRECTOR
Burke Barrett
CardioFocus, Inc. (sponsor)
- PRINCIPAL INVESTIGATOR
Vivek Reddy, MD
Mt. Sinai Hospital, NYC
- PRINCIPAL INVESTIGATOR
Andrea Natale, MD
Texas Cardiac Arrhythmia Research Foundation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2011
First Posted
October 20, 2011
Study Start
January 1, 2012
Primary Completion
December 1, 2014
Study Completion
January 1, 2016
Last Updated
September 8, 2016
Results First Posted
September 8, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share