Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

Sponsor

University of Utah (Other)

Overall Status

Unknown status

CT.gov ID

NCT04130061

Collaborator

(none)

Enrollment

Location

Arms

23.7

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Biological: Human Amniotic Membrane	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 11, 2019

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Randomized	Biological: Human Amniotic Membrane Epicardial application of human amniotic membrane during cardiac surgery
No Intervention: Control

Arm

Intervention/Treatment

Experimental: Randomized

Biological: Human Amniotic Membrane

Epicardial application of human amniotic membrane during cardiac surgery

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Safety assessment of the use of human amniotic membrane during cardiac surgery by incidence of adverse events [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).
Comparison of the incidence of Post Op Atrial Fibrillation between patients who receive hAM and controls [1 month]
The incidence of 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.
Comparison of inflammatory response (systemic and pericardial) between patients who received hAM and controls [1 month]
The proinflammatory response to cardiopulmonary bypass circuit as measured by numerous systemic and pericardial inflammatory markers i.e. C-reactive protein (CRP), TNF-α, Interleukin (IL)-6 and brain natriuretic peptide (BNP), have been linked to induction of atrial fibrillation. We will collect pericardial (from chest tubes) and systemic fluid markers at pre-specified intervals. We will assess the percentage change in the levels of the biomarkers as compared to their pre-operative baseline, as there will be expected variability in the level of these biomarkers at baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator: Vikas Sharma, MD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vikas Sharma, Associate Professor, University of Utah

ClinicalTrials.gov Identifier:

NCT04130061

Other Study ID Numbers:

00113483

First Posted:

Oct 17, 2019

Last Update Posted:

Feb 5, 2020

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Feb 5, 2020