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Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

NCT ID: NCT04130061

Last Updated: 2024-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-11

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Randomized

Group Type EXPERIMENTAL

Human Amniotic Membrane

Intervention Type BIOLOGICAL

Epicardial application of human amniotic membrane during cardiac surgery

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Human Amniotic Membrane

Epicardial application of human amniotic membrane during cardiac surgery

Intervention Type BIOLOGICAL

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Vikas Sharma

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vikas Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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00113483

Identifier Type: -

Identifier Source: org_study_id