Atrial FibrillationEarly Phase 1NCT04130061
Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation
A Early Phase 1 study testing Human Amniotic Membrane in people with Atrial Fibrillation, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Human Amniotic Membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 1 Jun 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary elective CABG at the University of Utah Hospital
- Ability to provided informed consent and follow-up with protocol procedures
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Human Amniotic Membrane
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Amniotic MembraneBiological
Epicardial application of human amniotic membrane during cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Randomized | Experimental | Not described Receives: Biological: Human Amniotic Membrane |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 1 month
proBNP (Serum) Between Groups at Time of Surgery
Comparison of serum levels of proBNP between groups at the time of surgery (baseline).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Surgery
proBNP (Serum) Between Groups at 24 Hours Post-op
Comparison of serum proBNP levels between groups at 24 hours post-op
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours
proBNP (Serum) Between Groups at 48 Hours Post-op
Comparison of serum levels of proBNP between groups at 48 hours post-op
Measured: 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
Measured: 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
Measured: 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
Measured: 48 hours
proBNP (Serum) Between Groups at 72 Hours Post-op
Comparison of serum levels of proBNP between groups at 72 hour post-op
Measured: 72 hours
CRP (Serum) Between Groups at 72 Hours Post-op
Comparison of serum levels of CRP between groups at 72 hour post-op
Measured: 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
Measured: 72 hours
TNFa (Serum) Between Groups at 72 Hours Post-op
Comparison of TNFa serum levels between groups at 72 hours post-op
Measured: 72 hours
proBNP (Serum) Between Groups at Follow-up
Comparison of serum levels of proBNP between groups at follow-up
Measured: 1 month
CRP (Serum) Between Groups at Follow-Up
Comparison of serum CRP levels between groups at follow-up
Measured: 1 month
Interleukin-6 (Serum) Between Groups at Follow-up
Comparison of IL-6 serum levels between groups at follow-up
Measured: 1 month
TNFa (Serum) Between Groups at Follow-up
Comparison of TNFa serum levels between groups at follow-up
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start11 Oct 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Vikas Sharma, University of Utah
- Investigators
- Vikas Sharma, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130061
- Sponsor's protocol ID
- 00113483
- Other IDs
- UL1TR002538
- Status last verified
- Dec 2024
- First submitted
- 14 Oct 2019
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT04130061
- Acronym / sponsor ID
- 00113483
- Conditions
- Atrial Fibrillation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized | Experimental | Biological: Human Amniotic Membrane |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing primary elective CABG at the University of Utah Hospital
- Ability to provided informed consent and follow-up with protocol procedures
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Amniotic MembraneEpicardial application of human amniotic membrane during cardiac surgery | Biological | Randomized |
Primary outcome
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).
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.
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).
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).
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).
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).
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
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
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
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
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
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
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
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
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
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
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
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
proBNP (Serum) Between Groups at Follow-up
Time frame: 1 month
Comparison of serum levels of proBNP between groups at follow-up
CRP (Serum) Between Groups at Follow-Up
Time frame: 1 month
Comparison of serum CRP levels between groups at follow-up
Interleukin-6 (Serum) Between Groups at Follow-up
Time frame: 1 month
Comparison of IL-6 serum levels between groups at follow-up
TNFa (Serum) Between Groups at Follow-up
Time frame: 1 month
Comparison of TNFa serum levels between groups at follow-up
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)
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).
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).
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).
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
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
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
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.
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.
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikas Sharma, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Human Amniotic Membrane in people with Atrial Fibrillation, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: 1 month). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.