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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
EAS-AC (HeartLight)
Control Arm Ablation
Sponsored by
CardioFocus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring atrial fibrillation, AF, PAF, PVI, ablation, paroxysmal atrial fibrillation, pulmonary vein isolation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama, Birmingham
  • Stanford Hospital
  • Regional Cardiology Associates, Mercy General Hospital
  • UCSF
  • Pacific Heart Institute
  • Mayo Clinic Jacksonville
  • Prairie Heart Institute
  • The University of Kansas Medical Center
  • Johns Hopkins
  • Massachusetts General Hospital
  • Beaumont Hospital
  • Mayo Clinic Rochester/St. Mary's Hospital
  • Mt. Sinai Hospital
  • Duke University
  • Hospital of the University of Pennsylvania
  • Medical University South Carolina
  • Texas Cardiac Arrhythmia Research Foundation
  • Methodist Hospital
  • Intermountain Medical Center
  • University of Virginia Health System
  • Sentara Cardiovascular Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EAS-AC (HeartLight)

Control Arm Ablation

Arm Description

Treatment with the EAS-AC.

Treatment with standard ablation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2011
Last Updated
July 25, 2016
Sponsor
CardioFocus
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1. Study Identification

Unique Protocol Identification Number
NCT01456000
Brief Title
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
Acronym
HeartLight
Official Title
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioFocus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
atrial fibrillation, AF, PAF, PVI, ablation, paroxysmal atrial fibrillation, pulmonary vein isolation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EAS-AC (HeartLight)
Arm Type
Experimental
Arm Description
Treatment with the EAS-AC.
Arm Title
Control Arm Ablation
Arm Type
Active Comparator
Arm Description
Treatment with standard ablation.
Intervention Type
Device
Intervention Name(s)
EAS-AC (HeartLight)
Intervention Description
Pulmonary vien isolation
Intervention Type
Procedure
Intervention Name(s)
Control Arm Ablation
Intervention Description
Treatment with standard ablation.
Primary Outcome Measure Information:
Title
Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burke Barrett
Organizational Affiliation
CardioFocus, Inc. (sponsor)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
Mt. Sinai Hospital, NYC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birminham
State/Province
Alabama
Country
United States
Facility Name
Stanford Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Regional Cardiology Associates, Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-1865
Country
United States
Facility Name
Prairie Heart Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Mayo Clinic Rochester/St. Mary's Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Mt. Sinai Hospital
City
NY
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26383722
Citation
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.
Results Reference
derived

Learn more about this trial

HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)

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