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HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)

NCT01456000 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2016-09-08

Study results available
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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.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

EAS-AC (HeartLight)

Pulmonary vien isolation

PROCEDURE

Control Arm Ablation

Treatment with standard ablation.

Sponsors & Collaborators

  • CardioFocus

    lead INDUSTRY

Principal Investigators

  • Burke Barrett · CardioFocus, Inc. (sponsor)

  • Vivek Reddy, MD · Mt. Sinai Hospital, NYC

  • Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-12-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456000 on ClinicalTrials.gov