Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

Utah System of Higher Education (USHE)

Status and phase: Completed; Early Phase 1

Conditions: Atrial Fibrillation

Treatments: Biological: Human Amniotic Membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT04130061

00113483

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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%

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Randomized

Experimental group

Treatment:

Biological: Human Amniotic Membrane

Control

No Intervention group