CONcomitant eValuation of Epicor Left atRial Therapy for AF
| Status: | Terminated |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/21/2019 |
| Start Date: | April 2009 |
| End Date: | March 2013 |
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).
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).
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
We found this trial at
15
sites
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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