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

Primary Purpose

Atrial Fibrillation

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Amniotic Membrane Patch

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Amniotic Membrane

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Arizona Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Amniotic membrane patch placement

Control

Arm Description

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 will not be placed after CABG procedure prior to wound closure.

Outcomes

Primary Outcome Measures

Rate of new onset postoperative atrial fibrillation

Secondary Outcome Measures

Procedure-related serious adverse events

Full Information

NCT ID

NCT02193321

First Posted

July 15, 2014

Last Updated

November 30, 2015

Sponsor

University of Arizona

Collaborators

PalinGen

1. Study Identification

Unique Protocol Identification Number

NCT02193321

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Withdrawn

Study Start Date

July 2014 (undefined)

Primary Completion Date

July 2015 (Anticipated)

Study Completion Date

July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Arizona

Collaborators

PalinGen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Atrial Fibrillation, Amniotic Membrane

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amniotic membrane patch placement

Arm Type

Experimental

Arm Description

One amniotic membrane patch will be placed on the epicardial surface of the heart immediately following a CABG procedure prior to wound closure.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Amniotic membrane patch will not be placed after CABG procedure prior to wound closure.

Intervention Type

Biological

Intervention Name(s)

Amniotic Membrane Patch

Other Intervention Name(s)

PalinGen KardiaMembrane, PalinGen Kardia XPlus Membrane

Primary Outcome Measure Information:

Title

Rate of new onset postoperative atrial fibrillation

Time Frame

up to 7 days

Secondary Outcome Measure Information:

Title

Procedure-related serious adverse events

Time Frame

up to 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zain I Khalpey, MD,PhD,MRCS

Organizational Affiliation

University of Arizona

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Arizona Medical Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15082699

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. doi: 10.1001/jama.291.14.1720.

Results Reference

background

PubMed Identifier

11747385

Citation

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.

Results Reference

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PubMed Identifier

17015402

Citation

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.

Results Reference

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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Citation

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

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