CONcomitant eValuation of Epicor Left atRial Therapy for AF
CONVERT-AF
1 other identifier
interventional
112
1 country
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Apr 2009
Typical duration for not_applicable atrial-fibrillation
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 22, 2007
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
May 5, 2014
CompletedFebruary 19, 2019
February 1, 2019
3.9 years
August 20, 2007
March 31, 2014
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Study Arms (1)
Epicor Cardiac Ablation
EXPERIMENTALInterventions
Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
Concomitant AF ablation during mitral valve surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
St. Agnes Medical Center
Fresno, California, 93720, United States
Manatee Memorial Hospital
Bradenton, Florida, 34208, United States
Blake Medical Center
Bradenton, Florida, 34209, United States
Cardiology Consultants, MD's PA (Baptist Hospital)
Pensacola, Florida, 32501, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Community Hospital
Munster, Indiana, 46321, United States
Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital
Baltimore, Maryland, 21218, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Minneapolis Heart Institute Foundation/Abbott NW Hospital
Minneapolis, Minnesota, 55407, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Mission Hospital, Inc
Asheville, North Carolina, 28801, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sue Walgren, Manager Sr., Clinical Project
- Organization
- St. Jude Medical
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Groh, MD
Mission Hospitals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 22, 2007
Study Start
April 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 19, 2019
Results First Posted
May 5, 2014
Record last verified: 2019-02