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NCT04130061 · ClinicalTrials.gov registry record · Early Phase 1
Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation
A Early Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 27
- Enrollment target
NCT04130061: Completed Early Phase 1 study, sponsored by University of Utah.
NCT04130061 is a Early Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 27 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04130061, a Early Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
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 expec
Interventions
- BIOLOGICAL Human Amniotic Membrane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2019-10-11 |
| Est. Completion | 2021-06-01 |
| Phase | Early Phase 1 |
What the finished NCT04130061 record still lists
NCT04130061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 1 intervention - of which Human Amniotic Membrane is the first listed.
NCT04130061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04130061 about?
NCT04130061 is a clinical study titled "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.
What is the current status of trial NCT04130061?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 27 participants. The study started on 2019-10-11. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT04130061?
The interventions under investigation include: Human Amniotic Membrane (BIOLOGICAL).
Who is sponsoring clinical trial NCT04130061?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04130061's enrollment target sits among peer trials
27 963rd of 2000 higher than 1,024 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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