HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF) (HeartLight)

July 25, 2016 updated by: CardioFocus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

405

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birminham, Alabama, United States
        • University of Alabama, Birmingham
    • California
      • Palo Alto, California, United States, 94305
        • Stanford Hospital
      • Sacramento, California, United States, 95819
        • Regional Cardiology Associates, Mercy General Hospital
      • San Francisco, California, United States, 94143
        • UCSF
      • Santa Monica, California, United States, 90404
        • Pacific Heart Institute
    • Florida
      • Jacksonville, Florida, United States, 32224-1865
        • Mayo Clinic Jacksonville
    • Illinois
      • Springfield, Illinois, United States, 62701
        • Prairie Heart Institute
    • Kansas
      • Kansas City, Kansas, United States
        • The University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Royal Oak, Michigan, United States, 48072
        • Beaumont Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Rochester/St. Mary's Hospital
    • New York
      • NY, New York, United States, 10029
        • Mt. Sinai Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of The University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University South Carolina
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Houston, Texas, United States, 77030
        • Methodist Hospital
    • Utah
      • Murray, Utah, United States
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Norfolk, Virginia, United States, 23507
        • Sentara Cardiovascular Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EAS-AC (HeartLight)
Treatment with the EAS-AC.
Device: EAS-AC (HeartLight)
Pulmonary vien isolation
Active Comparator: Control Arm Ablation
Treatment with standard ablation.
Procedure: Control Arm Ablation
Treatment with standard ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioFocus

Investigators

  • Study Director: Burke Barrett, CardioFocus, Inc. (sponsor)
  • Principal Investigator: Vivek Reddy, MD, Mt. Sinai Hospital, NYC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 17, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-3002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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