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

July 27, 2016 updated by: CardioFocus
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Santa Monica, California, United States, 90404
        • Pacific Heart Institute
    • Michigan
      • Royal Oak, Michigan, United States, 48072
        • William Beaumont Hospital
    • New York
      • New York, New York, United States, 10029
        • Mt. Sinai Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 70 years
  • paroxysmal atrial fibrillation
  • failure of at least one AAD
  • others

Exclusion Criteria:

  • overall good health as established by multiple criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with HeartLight System
Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System
Device: CardioFocus HeartLight Endoscopic Ablation System
PVI ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Recurrence of Atrial Fibrillation
Time Frame: 12 months
Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioFocus

Investigators

  • Study Director: Burke Barret, CardioFocus, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-2734

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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