Clinical trial NCT01456000: HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paroxysmal Atrial Fibrillation
Keywords: atrial fibrillation
AF
PAF
PVI
ablation
paroxysmal atrial fibrillation
pulmonary vein isolation
Lead sponsor: CardioFocus
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birminham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates, Mercy General Hospital
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Springfield
country: United States
facility: Prairie Heart Institute
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester/St. Mary's Hospital
state: Minnesota
city: NY
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University South Carolina
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
Study officials:
affiliation: CardioFocus, Inc. (sponsor)
name: Burke Barrett
role: STUDY_DIRECTOR
affiliation: Mt. Sinai Hospital, NYC
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.