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Completed

NCT Number: NCT01456000

HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama, Birmingham, Birminham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EAS-AC (HeartLight)

Device

Pulmonary vien isolation

Control Arm Ablation

Procedure

Treatment with standard ablation.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

CardioFocus

Industry

Registry information

Official study title

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

Acronym: HeartLight

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Oct 20, 2011
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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