NCT04130061

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

December 6, 2024

Completed
Last Updated

April 9, 2026

Status Verified

December 1, 2024

Enrollment Period

1.6 years

First QC Date

October 14, 2019

Results QC Date

May 9, 2022

Last Update Submit

April 7, 2026

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (38)

  • 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

Study Arms (2)

Randomized

EXPERIMENTAL
Biological: Human Amniotic Membrane

Control

NO INTERVENTION

Interventions

Human Amniotic MembraneBIOLOGICAL

Epicardial application of human amniotic membrane during cardiac surgery

Randomized

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Vikas Sharma, MD
Organization
University of Utah
vikas.sharma@hsc.utah.edu
801-581-5311

Study Officials

  • Vikas Sharma, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 17, 2019

Study Start

October 11, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

April 9, 2026

Results First Posted

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)