A Phase 1/2 interventional study of Amniotic Membrane Patch in Atrial Fibrillation, sponsored by University of Arizona. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by University of Arizona · Phase 1/2, Interventional, and Treatment
The purpose of this study is to to evaluate the rate of new onset postoperative atrial fibrillation in subjects receiving the amniotic membrane patch placed on the epicardial surface as compared to subjects who did not undergo epicardium intervention.
New onset postoperative atrial fibrillation (NOPAF) presents in approximately 27 to 40% of patients who have recently undergone coronary artery bypass graft (CABG) or other open heart surgeries. NOPAF can put patients at clinical risk for stroke and other arrhythmias. NOPAF commonly prolongs hospitalization leading to increased use of hospital resources, higher cost and decreased patient satisfaction. A number of risk factors have been associated with the development of NOPAF including age, prior history of atrial fibrillation, Chronic Obstructive Pulmonary Disease (COPD), chronic renal failure, diabetes and obesity. It is not entirely clear what causes NOPAF; the prevailing theory is that it is a multi-factorial process, possibly due in part to inflammation from the surgery. The usual treatments for NOPAF are associated with various side effects and risks. We propose to test the hypothesis that an amniotic membrane patch, with minimal known risk and side effects, placed on the heart's surface during surgery will reduce the incidence of NOPAF.
This phase I/II prospective, single-center, randomized controlled clinical trial is being undertaken to assess the safety of the amniotic membrane patch when used in the setting of CABG surgery and whether utilization of the amniotic membrane patch to aid repair of the normal epicardium following isolated, first-time CABG procedures might result in a lower rate of NOPAF compared to subjects who did not undergo treatment with the amniotic membrane patch.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
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Inclusion Criteria:
Preoperative Exclusion Criteria:
Intraoperative Exclusion Criteria:
Postoperative Exclusion Criteria:
One amniotic membrane patch will be placed on the epicardial surface of the heart immediately following a CABG procedure prior to wound closure.
Biological: Amniotic Membrane Patch
Amniotic membrane patch will not be placed after CABG procedure prior to wound closure.
Also known as: PalinGen KardiaMembrane, PalinGen Kardia XPlus Membrane
Rate of new onset postoperative atrial fibrillation
Time frame: up to 7 days
Procedure-related serious adverse events
Time frame: up to 30 days
This study is withdrawn, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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University of Arizona