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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epicor LP Cardiac Ablation System
Surgical ablation of permanent AF
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Arrhythmia, Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Agnes Medical Center
  • Manatee Memorial Hospital
  • Blake Medical Center
  • Cardiology Consultants, MD's PA (Baptist Hospital)
  • NorthShore University Health System
  • Community Hospital
  • Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital
  • William Beaumont Hospital
  • Minneapolis Heart Institute Foundation/Abbott NW Hospital
  • HealthEast St. Joseph's Hospital
  • Hackensack University Medical Center
  • University of Rochester Medical Center
  • St. Francis Hospital
  • Mission Hospital, Inc
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epicor Cardiac Ablation

Arm Description

Outcomes

Primary Outcome Measures

Freedom From Atrial Fibrillation in the Absence of Any AF Therapies
Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.

Secondary Outcome Measures

Full Information

First Posted
August 20, 2007
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00519194
Brief Title
CONcomitant eValuation of Epicor Left atRial Therapy for AF
Acronym
CONVERT-AF
Official Title
CONcomitant eValuation of Epicor Left atRial Therapy for AF
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Arrhythmia, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epicor Cardiac Ablation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Epicor LP Cardiac Ablation System
Intervention Description
Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
Intervention Type
Procedure
Intervention Name(s)
Surgical ablation of permanent AF
Intervention Description
Concomitant AF ablation during mitral valve surgery
Primary Outcome Measure Information:
Title
Freedom From Atrial Fibrillation in the Absence of Any AF Therapies
Description
Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Groh, MD
Organizational Affiliation
Mission Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Agnes Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Manatee Memorial Hospital
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Blake Medical Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Cardiology Consultants, MD's PA (Baptist Hospital)
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Community Hospital
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Minneapolis Heart Institute Foundation/Abbott NW Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
HealthEast St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Mission Hospital, Inc
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CONcomitant eValuation of Epicor Left atRial Therapy for AF

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