NCT04130061

Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

Completed EARLY_PHASE1 Results posted Last updated 9 April 2026

What this trial tests

EARLY_PHASE1 trial testing Human Amniotic Membrane in Atrial Fibrillation in 27 participants. Completed in 1 June 2021.

Timeline

11 October 2019

Primary endpoint
1 June 2021

1 June 2021

Quick facts

Lead sponsor	University of Utah
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	27
Start date	11 October 2019
Primary completion	1 June 2021
Estimated completion	1 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Human Amniotic Membrane — full drug profile →

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

University of Utah

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · 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).

Group	Value	95% CI
Randomized	0
Control	0

Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls Primary · 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.

Group	Value	95% CI
Randomized	5
Control	6

proBNP (Serum) Between Groups at Time of Surgery Primary · Surgery

Comparison of serum levels of proBNP between groups at the time of surgery (baseline).

Group	Value	95% CI
Randomized	198	± 263
Control	347	± 523

C-reactive Protein (Serum) Between Groups at Time of Surgery Primary · Surgery

Comparison of serum levels of CRP between groups at the time of surgery (baseline).

Group	Value	95% CI
Randomized	0.34	± 0.32
Control	0.39	± 0.87

Interleukin-6 (Serum) Between Groups at Time of Surgery Primary · Surgery

Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline).

Group	Value	95% CI
Randomized	2.25	± 0.86
Control	2.23	± 0.83

Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery Primary · Surgery

Comparison of serum levels of TNFa between groups at the time of surgery (baseline).

Group	Value	95% CI
Randomized	2.45	± 1.56
Control	3.63	± 3.04

proBNP (Serum) Between Groups at 24 Hours Post-op Primary · 24 hours

Comparison of serum proBNP levels between groups at 24 hours post-op

Group	Value	95% CI
Randomized	1922.83	± 1017.9
Control	2239.42	± 2384.3

C-reactive Protein (Serum) Between Groups at 24-hours Post-op Primary · 24 hours

Comparison of serum measurements of CRP between groups at 24 hours post-op

Group	Value	95% CI
Randomized	14.94	± 5.94
Control	10.66	± 4.58

Interleukin-6 (Serum) Between Groups at 24-hours Post-op Primary · 24 hours

Comparison of IL-6 serum levels between groups at 24 hours post-op

Group	Value	95% CI
Randomized	26.95	± 22.36
Control	18.28	± 12.03

Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op Primary · 24 hours

Comparison of serum levels of TNFa between groups at 24 hours post-op

Group	Value	95% CI
Randomized	2.61	± 1.22
Control	2.87	± 2.72

proBNP (Serum) Between Groups at 48 Hours Post-op Primary · 48 hours

Comparison of serum levels of proBNP between groups at 48 hours post-op

Group	Value	95% CI
Randomized	6081.83	± 5134.12
Control	7750.35	± 7474.25

C-reactive Protein (Serum) Between Groups at 48 Hours Post-op Primary · 48 hours

Comparison of serum CRP levels between groups at 48 hours post-op

Group	Value	95% CI
Randomized	21.67	± 8.18
Control	15.71	± 6.97

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.