Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

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: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Biological: Human Amniotic Membrane

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Early Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	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	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	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	Comparison of serum levels of CRP between groups at the time of surgery (baseline).	Surgery
Interleukin-6 (Serum) Between Groups at Time of 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	Comparison of serum levels of TNFa between groups at the time of surgery (baseline).	Surgery
proBNP (Serum) Between Groups at 24 Hours Post-op	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	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	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	Comparison of serum levels of TNFa between groups at 24 hours post-op	24 hours
proBNP (Serum) Between Groups at 48 Hours Post-op	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	Comparison of serum CRP levels between groups at 48 hours post-op	48 hours
Interleukin-6 (Serum) Between Groups at 48 Hours Post-op	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	Comparison of serum TNFa levels between groups at 48 hours post-op	48 hours
proBNP (Serum) Between Groups at 72 Hours Post-op	Comparison of serum levels of proBNP between groups at 72 hour post-op	72 hours
CRP (Serum) Between Groups at 72 Hours Post-op	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	Comparison of IL-6 serum levels between groups at 72 hours post-op	72 hours
TNFa (Serum) Between Groups at 72 Hours Post-op	Comparison of TNFa serum levels between groups at 72 hours post-op	72 hours
proBNP (Serum) Between Groups at Follow-up	Comparison of serum levels of proBNP between groups at follow-up	1 month
CRP (Serum) Between Groups at Follow-Up	Comparison of serum CRP levels between groups at follow-up	1 month
Interleukin-6 (Serum) Between Groups at Follow-up	Comparison of IL-6 serum levels between groups at follow-up	1 month
TNFa (Serum) Between Groups at Follow-up	Comparison of TNFa serum levels between groups at follow-up	1 month
proBNP (Pericardial Fluid) Between Groups at Time of 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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op	72 hours

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Vikas Sharma, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID 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