CONcomitant eValuation of Epicor Left atRial Therapy for AF (CONVERT-AF)

February 1, 2019 updated by: Abbott Medical Devices
The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac Ablation System for treating permanent atrial fibrillation during concomitant open chest and/or open heart surgery for one of more of the following procedures: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, coronary artery bypass surgery or patent foramen ovale (PFO closure).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

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
    • California
      • Fresno, California, United States, 93720
        • St. Agnes Medical Center
    • Florida
      • Bradenton, Florida, United States, 34208
        • Manatee Memorial Hospital
      • Bradenton, Florida, United States, 34209
        • Blake Medical Center
      • Pensacola, Florida, United States, 32501
        • Cardiology Consultants, MD's PA (Baptist Hospital)
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System
    • Indiana
      • Munster, Indiana, United States, 46321
        • Community Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation/Abbott NW Hospital
      • Saint Paul, Minnesota, United States, 55102
        • HealthEast St. Joseph's Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital, Inc
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-80 years old
  • Permanent AF defined as continuous AF lasting > one year OR non self-terminating AF lasting > seven days but no more than one year with at least one failed DC cardioversion
  • Have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (PFO) closure or coronary artery bypass surgery
  • Be able to take anticoagulation therapy
  • Be able to fulfill study requirements
  • Be able to sign study-specific informed consent

Exclusion Criteria:

  • Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy
  • Prior cardiac surgery
  • Presence of active endocarditis, local or system infection
  • Presence of advanced heart failure (NYHA class > II, & LVEF < 20%)
  • Intraaortic balloon pump, IV inotropes or vasoactive agents within 30 days
  • Emergent cardiac surgery due to acute MI or acute mitral regurgitation
  • Life expectancy < 1 year
  • Major or progressive non-cardiac disease
  • Presence of left atrial thrombi
  • Left atrial diameter > 6.0 cm
  • Any condition that prevents investigator from safely performing procedure
  • Positive urine or serum pregnancy test
  • Prior left atrial ablation
  • Currently participating in another clinical research study

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Epicor Cardiac Ablation
Device: Epicor LP Cardiac Ablation System
Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
Procedure: Surgical ablation of permanent AF
Concomitant AF ablation during mitral valve surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Atrial Fibrillation in the Absence of Any AF Therapies
Time Frame: 6 months
Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.
6 months

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Mark Groh, MD, Mission Hospitals

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

April 1, 2009

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (ESTIMATE)

August 22, 2007

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051.13

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.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Epicor LP Cardiac Ablation System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe