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Completed Phase 3 Interventional Results available

HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)

ClinicalTrials.gov ID: NCT01456000

Public ClinicalTrials.gov record NCT01456000. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 9:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01456000
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
CardioFocus
Industry
Enrollment
405 participants

Conditions and interventions

Interventions

Device · Procedure

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2011
Primary completion
Nov 30, 2014
Completion
Dec 31, 2015
Last update posted
Sep 7, 2016

2012 – 2016

United States locations

U.S. sites
21
U.S. states
16
U.S. cities
21
Facility City State ZIP Site status
University of Alabama, Birmingham Birminham Alabama
Stanford Hospital Palo Alto California 94305
Regional Cardiology Associates, Mercy General Hospital Sacramento California 95819
UCSF San Francisco California 94143
Pacific Heart Institute Santa Monica California 90404
Mayo Clinic Jacksonville Jacksonville Florida 32224-1865
Prairie Heart Institute Springfield Illinois 62701
The University of Kansas Medical Center Kansas City Kansas
Johns Hopkins Baltimore Maryland 21287
Massachusetts General Hospital Boston Massachusetts 02114
Beaumont Hospital Royal Oak Michigan 48072
Mayo Clinic Rochester/St. Mary's Hospital Rochester Minnesota 55902
Mt. Sinai Hospital New York New York 10029
Duke University Durham North Carolina 27710
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104
Medical University South Carolina Charleston South Carolina 29425
Texas Cardiac Arrhythmia Research Foundation Austin Texas 78705
Methodist Hospital Houston Texas 77030
Intermountain Medical Center Murray Utah
University of Virginia Health System Charlottesville Virginia 22908
Sentara Cardiovascular Research Institute Norfolk Virginia 23507

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01456000, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 7, 2016 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01456000 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →