Safety and Efficacy Study of Amniotic Membrane Patch to Treat Postoperative Atrial Fibrillation
NCT ID: NCT02193321
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2014-07-31
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Amniotic membrane patch placement
One amniotic membrane patch will be placed on the epicardial surface of the heart immediately following a CABG procedure prior to wound closure.
Amniotic Membrane Patch
Control
Amniotic membrane patch will not be placed after CABG procedure prior to wound closure.
No interventions assigned to this group
Interventions
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Amniotic Membrane Patch
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* This cardiac operation is the subject's first or primary cardiac operation
* The subject must be undergoing an isolated CABG procedure using a median sternotomy approach
* Must have ability to provide written informed consent
* Must have ability to fulfill all of the expected requirements of this clinical protocol
Exclusion Criteria
* Prior history of open heart surgery
* Prior history of pericarditis
* Prior history of anti-arrhythmia drug treatment (e.g., amiodarone, dronedarone, or sotalol) in the past six months
* The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers)
* Concomitant procedure planned
* In the investigator's opinion, the subject may require prophylactic treatment with anti-arrhythmia drugs or temporary pacing postoperatively
* Unexpected procedure (i.e., valve repair/replacement) or intraoperative findings creating an unreasonable intraoperative risk or an increased probability of postoperative complications in terms of recovery.
* CABG procedure with \> 3 hours total on (cardiopulmonary bypass) CPB.
* Prophylactic use of amiodarone.
* Prophylactic use of amiodarone
* No prophylactic, temporary pacing except for symptomatic bradycardia or advanced heart black as defined as:
* Sinus bradycardia \< 40 beats per minute
* Type 1 atrioventricular (AV) block
* Type 2 AV block
* Complete block
18 Years
ALL
No
Sponsors
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PalinGen
OTHER
University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Zain I Khalpey, MD,PhD,MRCS
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona Medical Center
Tucson, Arizona, United States
Countries
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References
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Mathew JP, Fontes ML, Tudor IC, Ramsay J, Duke P, Mazer CD, Barash PG, Hsu PH, Mangano DT; Investigators of the Ischemia Research and Education Foundation; Multicenter Study of Perioperative Ischemia Research Group. A multicenter risk index for atrial fibrillation after cardiac surgery. JAMA. 2004 Apr 14;291(14):1720-9. doi: 10.1001/jama.291.14.1720.
Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. doi: 10.7326/0003-4819-135-12-200112180-00010.
Burgess DC, Kilborn MJ, Keech AC. Interventions for prevention of post-operative atrial fibrillation and its complications after cardiac surgery: a meta-analysis. Eur Heart J. 2006 Dec;27(23):2846-57. doi: 10.1093/eurheartj/ehl272. Epub 2006 Oct 2.
Maddox TM, Nash IS, Fuster V. Economic costs associated with atrial fibrillation. In: Natale A, Jalife J, ed 1. Atrial Fibrillation: from bench to bedside. Humana press: 13-26, 2008.
Hamilton DR, Dani RS, Semlacher RA, Smith ER, Kieser TM, Tyberg JV. Right atrial and right ventricular transmural pressures in dogs and humans. Effects of the pericardium. Circulation. 1994 Nov;90(5):2492-500. doi: 10.1161/01.cir.90.5.2492.
Crystal E, Connolly SJ, Sleik K, Ginger TJ, Yusuf S. Interventions on prevention of postoperative atrial fibrillation in patients undergoing heart surgery: a meta-analysis. Circulation. 2002 Jul 2;106(1):75-80. doi: 10.1161/01.cir.0000021113.44111.3e.
Guo Y, Lip GY, Apostolakis S. Inflammation in atrial fibrillation. J Am Coll Cardiol. 2012 Dec 4;60(22):2263-70. doi: 10.1016/j.jacc.2012.04.063.
Cargnoni A, Di Marcello M, Campagnol M, Nassuato C, Albertini A, Parolini O. Amniotic membrane patching promotes ischemic rat heart repair. Cell Transplant. 2009;18(10):1147-59. doi: 10.3727/096368909X12483162196764. Epub 2009 Jun 22.
Kim HG, Choi OH. Neovascularization in a mouse model via stem cells derived from human fetal amniotic membranes. Heart Vessels. 2011 Mar;26(2):196-205. doi: 10.1007/s00380-010-0064-6. Epub 2010 Dec 25.
Toda A, Okabe M, Yoshida T, Nikaido T. The potential of amniotic membrane/amnion-derived cells for regeneration of various tissues. J Pharmacol Sci. 2007 Nov;105(3):215-28. doi: 10.1254/jphs.cr0070034. Epub 2007 Nov 6.
Dobaczewski M, Gonzalez-Quesada C, Frangogiannis NG. The extracellular matrix as a modulator of the inflammatory and reparative response following myocardial infarction. J Mol Cell Cardiol. 2010 Mar;48(3):504-11. doi: 10.1016/j.yjmcc.2009.07.015. Epub 2009 Jul 23.
Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds. 2012 Oct;24(10):299-307.
Other Identifiers
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1405313630
Identifier Type: -
Identifier Source: org_study_id