Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

April 7, 2026 updated by: Vikas Sharma, University of Utah

Safety and Feasibility Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation After Coronary Artery Bypass Grafting

This study will evaluate the application of hAM at the time of cardiac surgery to decrease inflammation and the subsequent substrate to reduce incidence of post-operative atrial fibrillation. Patients will randomized 1:1 to receive either hAM application or standard of care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing primary elective CABG at the University of Utah Hospital
  • Ability to provided informed consent and follow-up with protocol procedures

Exclusion Criteria:

  • Patients in AF at the time of surgery
  • Prior history of sternotomy
  • Prior history of pericarditis
  • Currently on aggressive antiarrhythmic therapy (does not include beta blockers)
  • Patients with an implantable cardiac device (pacemaker, ICD, CRT-D)
  • Ejection fraction <45%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Randomized
Biological: Human Amniotic Membrane
Epicardial application of human amniotic membrane during cardiac surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 1 month
The AM applied epicardially will be assessed for signs of hyperacute rejection i.e. membrane changing color; cardiac tamponade or constriction assessed by echocardiogram and transmission of infectious diseases. The incidence of adverse events (AEs) will be reported as percentages, with two-sided 95% confidence intervals. Statistical comparisons of AEs between the AM treatment and the control group will be made using a chi-square, or Fisher's exact test, as appropriate (based on the minimum expected cell frequencies).
1 month
Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls
Time Frame: 1 month
The number of patients with Post Op Atrial Fibrillation will be compared between the treatment and control group using mobile telemetry. This comparison will be analyzed using chi-square or Fisher's exact test as appropriate.
1 month
proBNP (Serum) Between Groups at Time of Surgery
Time Frame: Surgery
Comparison of serum levels of proBNP between groups at the time of surgery (baseline).
Surgery
C-reactive Protein (Serum) Between Groups at Time of Surgery
Time Frame: Surgery
Comparison of serum levels of CRP between groups at the time of surgery (baseline).
Surgery
Interleukin-6 (Serum) Between Groups at Time of Surgery
Time Frame: Surgery
Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline).
Surgery
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery
Time Frame: Surgery
Comparison of serum levels of TNFa between groups at the time of surgery (baseline).
Surgery
proBNP (Serum) Between Groups at 24 Hours Post-op
Time Frame: 24 hours
Comparison of serum proBNP levels between groups at 24 hours post-op
24 hours
C-reactive Protein (Serum) Between Groups at 24-hours Post-op
Time Frame: 24 hours
Comparison of serum measurements of CRP between groups at 24 hours post-op
24 hours
Interleukin-6 (Serum) Between Groups at 24-hours Post-op
Time Frame: 24 hours
Comparison of IL-6 serum levels between groups at 24 hours post-op
24 hours
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op
Time Frame: 24 hours
Comparison of serum levels of TNFa between groups at 24 hours post-op
24 hours
proBNP (Serum) Between Groups at 48 Hours Post-op
Time Frame: 48 hours
Comparison of serum levels of proBNP between groups at 48 hours post-op
48 hours
C-reactive Protein (Serum) Between Groups at 48 Hours Post-op
Time Frame: 48 hours
Comparison of serum CRP levels between groups at 48 hours post-op
48 hours
Interleukin-6 (Serum) Between Groups at 48 Hours Post-op
Time Frame: 48 hours
Comparison of IL-6 serum results between groups at 48 hours post-op
48 hours
Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op
Time Frame: 48 hours
Comparison of serum TNFa levels between groups at 48 hours post-op
48 hours
proBNP (Serum) Between Groups at 72 Hours Post-op
Time Frame: 72 hours
Comparison of serum levels of proBNP between groups at 72 hour post-op
72 hours
CRP (Serum) Between Groups at 72 Hours Post-op
Time Frame: 72 hours
Comparison of serum levels of CRP between groups at 72 hour post-op
72 hours
Interleukin-6 (Serum) Between Groups at 72 Hours Post-op
Time Frame: 72 hours
Comparison of IL-6 serum levels between groups at 72 hours post-op
72 hours
TNFa (Serum) Between Groups at 72 Hours Post-op
Time Frame: 72 hours
Comparison of TNFa serum levels between groups at 72 hours post-op
72 hours
proBNP (Serum) Between Groups at Follow-up
Time Frame: 1 month
Comparison of serum levels of proBNP between groups at follow-up
1 month
CRP (Serum) Between Groups at Follow-Up
Time Frame: 1 month
Comparison of serum CRP levels between groups at follow-up
1 month
Interleukin-6 (Serum) Between Groups at Follow-up
Time Frame: 1 month
Comparison of IL-6 serum levels between groups at follow-up
1 month
TNFa (Serum) Between Groups at Follow-up
Time Frame: 1 month
Comparison of TNFa serum levels between groups at follow-up
1 month
proBNP (Pericardial Fluid) Between Groups at Time of Surgery
Time Frame: Surgery
Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline)
Surgery
C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery
Time Frame: Surgery
Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline).
Surgery
Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery
Time Frame: Surgery
Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline).
Surgery
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery
Time Frame: Surgery
Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline).
Surgery
proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op
Time Frame: 24 hours
Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op
24 hours
C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op
Time Frame: 24 hours
Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op
24 hours
Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op
Time Frame: 24 hours
Comparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op
24 hours
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op
Time Frame: 24 hours
Comparison of TNFa in pericardial fluid between groups at 24 hours post-op.
24 hours
proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op
Time Frame: 48 hours
Comparison of proBNP levels in pericardial fluid between groups at 48 hours post-op.
48 hours
C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op
Time Frame: 48 hours
Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op
48 hours
Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op
Time Frame: 48 hours
Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op
48 hours
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op
Time Frame: 48 hours
Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op
48 hours
proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op
Time Frame: 72 hours
Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op
72 hours
C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op
Time Frame: 72 hours
Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op
72 hours
Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op
Time Frame: 72 hours
Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op
72 hours
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op
Time Frame: 72 hours
Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Advancing Translational Sciences (NCATS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vikas Sharma, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00113483
  • UL1TR002538 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings