Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04130061
• Other study ID #: 00113483
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 11, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2019
• Source: University of Utah
• Contact: Vikas Sharma, MD
• Phone: (801) 581-5311
• Email: vikas.sharma[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Biological:
• Human Amniotic Membrane
Epicardial application of human amniotic membrane during cardiac surgery

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment of the use of human amniotic membrane during cardiac surgery by incidence of 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
Primary	Comparison of the incidence of Post Op Atrial Fibrillation between patients who receive hAM and controls	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.	1 month
Primary	Comparison of inflammatory response (systemic and pericardial) between patients who received hAM and controls	The proinflammatory response to cardiopulmonary bypass circuit as measured by numerous systemic and pericardial inflammatory markers i.e. C-reactive protein (CRP), TNF-a, 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.	1 month