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Completed

NCT Number: NCT04130061

Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Human Amniotic Membrane

Biological

Epicardial application of human amniotic membrane during cardiac surgery

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. proBNP (Serum) Between Groups at Follow-up

    Time frame: 1 month

    Comparison of serum levels of proBNP between groups at follow-up

  20. CRP (Serum) Between Groups at Follow-Up

    Time frame: 1 month

    Comparison of serum CRP levels between groups at follow-up

  21. Interleukin-6 (Serum) Between Groups at Follow-up

    Time frame: 1 month

    Comparison of IL-6 serum levels between groups at follow-up

  22. TNFa (Serum) Between Groups at Follow-up

    Time frame: 1 month

    Comparison of TNFa serum levels between groups at follow-up

  23. 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)

  24. 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).

  25. 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).

  26. 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).

  27. 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

  28. 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

  29. 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

  30. 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.

  31. 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.

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 17, 2019
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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