Safety and Efficacy Study of Amniotic Membrane Patch to Treat Postoperative Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving an Amniotic Membrane Patch Placed on the Epicardial Surface

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02193321
• Other study ID #: 1405313630
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: July 15, 2014
• Last updated: November 30, 2015
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• 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

Preoperative Exclusion Criteria:

• Prior history of atrial fibrillation

• 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

Intraoperative Exclusion Criteria:

• 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.

Postoperative Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Biological:
• Amniotic Membrane Patch

Locations

Country	Name	City	State
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	PalinGen

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. Epub 2006 Oct 2. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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.

Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. Review. — View Citation

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. — View Citation

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. Epub 2007 Nov 6. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of new onset postoperative atrial fibrillation		up to 7 days	No
Secondary	Procedure-related serious adverse events		up to 30 days	Yes