CONVERT-AF: CONcomitant eValuation of Epicor Left atRial Therapy for AF
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Freedom From Atrial Fibrillation in the Absence of Any AF Therapies [6 months]
Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Agnes Medical Center | Fresno | California | United States | 93720 |
| 2 | Manatee Memorial Hospital | Bradenton | Florida | United States | 34208 |
| 3 | Blake Medical Center | Bradenton | Florida | United States | 34209 |
| 4 | Cardiology Consultants, MD's PA (Baptist Hospital) | Pensacola | Florida | United States | 32501 |
| 5 | NorthShore University Health System | Evanston | Illinois | United States | 60201 |
| 6 | Community Hospital | Munster | Indiana | United States | 46321 |
| 7 | Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital | Baltimore | Maryland | United States | 21218 |
| 8 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 9 | Minneapolis Heart Institute Foundation/Abbott NW Hospital | Minneapolis | Minnesota | United States | 55407 |
| 10 | HealthEast St. Joseph's Hospital | Saint Paul | Minnesota | United States | 55102 |
| 11 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 12 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 13 | St. Francis Hospital | Roslyn | New York | United States | 11576 |
| 14 | Mission Hospital, Inc | Asheville | North Carolina | United States | 28801 |
| 15 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Mark Groh, MD, Mission Hospitals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 051.13
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Epicor Cardiac Ablation |
|---|---|
| Arm/Group Description | Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure |
| Period Title: Overall Study | |
| STARTED | 112 |
| COMPLETED | 91 |
| NOT COMPLETED | 21 |
Baseline Characteristics
| Arm/Group Title | Epicor Cardiac Ablation |
|---|---|
| Arm/Group Description | Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery |
| Overall Participants | 112 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
72.4
(6.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
45
40.2%
|
| Male |
67
59.8%
|
| Region of Enrollment (participants) [Number] | |
| United States |
112
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Epicor Cardiac Ablation |
|---|---|
| Arm/Group Description | Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery |
| Measure Participants | 91 |
| Number [participants] |
49
43.8%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Epicor Cardiac Ablation | |
| Arm/Group Description | Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery | |
All Cause Mortality |
||
| Epicor Cardiac Ablation | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Epicor Cardiac Ablation | ||
| Affected / at Risk (%) | # Events | |
| Total | 11/112 (9.8%) | |
| Cardiac disorders | ||
| Cardiac injury related to Epicor device rsulting in unplanned surgical or catheter intervention | 1/112 (0.9%) | 1 |
| Death | 3/112 (2.7%) | 3 |
| Myocardial infarction | 1/112 (0.9%) | 1 |
| Newly developed third degree AV block requiring permanent pacemaker implantation | 4/112 (3.6%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pulmonary embolism | 1/112 (0.9%) | 1 |
| Vascular disorders | ||
| Peripheral arterial embolism | 1/112 (0.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Epicor Cardiac Ablation | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/112 (0.9%) | |
| Cardiac disorders | ||
| Acute heart failure | 1/112 (0.9%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Sue Walgren, Manager Sr., Clinical Project |
|---|---|
| Organization | St. Jude Medical |
| Phone | 6517563210 |
| swalgren@sjm.com |
- 051.13