Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)

NCT ID: NCT02073331

Last Updated: 2023-07-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-12-31

Brief Summary

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The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.

Detailed Description

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Up to 100 clinical sites will enroll subjects who have received CorMatrix ECM for pericardial reconstruction.

The following clinical data will be collected at a single post-operative visit:

* Demographic information
* Pre-operative risk factors
* Surgical procedure
* Blood transfusion information, if applicable
* Chest tube placement information
* Surgical complications
* Use of anticoagulation medication
* Cardiac related procedures since surgical procedure
* Device related adverse events

Conditions

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Coronary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CorMatrix ECM

Data collection for information on the use of CorMatrix ECM for pericardial reconstruction

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects who have received CorMatrix ECM for pericardial reconstruction
* Sign an Informed Consent

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elutia Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Green

Role: STUDY_DIRECTOR

Elutia Inc.

Locations

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Cario-Thoracic Surgeons, P.C.

Birmingham, Alabama, United States

Site Status

Cardiovascular Consultants, LTD

Glendale, Arizona, United States

Site Status

Phoenix Cardiac Surgery

Phoenix, Arizona, United States

Site Status

Southwest Heart & Lung

Phoenix, Arizona, United States

Site Status

University of Arizona Medical Center

Tucson, Arizona, United States

Site Status

Mercy Clinic Cardiac Thoracic & Vascular Surgery

Fort Smith, Arkansas, United States

Site Status

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Site Status

Baptist Medical Center

Little Rock, Arkansas, United States

Site Status

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Site Status

Heart & Lung Surgical Specialties

Rancho Mirage, California, United States

Site Status

Stockton Cardiothoracic Surgical Medical Group

Stockton, California, United States

Site Status

Hartford Healthcare Medical Group

Hartford, Connecticut, United States

Site Status

Tenet Florida Physician Services

Delray Beach, Florida, United States

Site Status

South Florida Heart & Lung Institute

Doral, Florida, United States

Site Status

Cardiothoracic & Vascular Surgical Associates

Jacksonville, Florida, United States

Site Status

David L. Galbut, MD & Associates

Miami, Florida, United States

Site Status

Palm Beach Gardens Medical Center

Palm Beach Gardens, Florida, United States

Site Status

Coastal Cardiovascular Surgeons

Panama City, Florida, United States

Site Status

Southern Cardiac & Vascular Associates

Tallahassee, Florida, United States

Site Status

Cardio Thoracic Vascular Surgery

Macon, Georgia, United States

Site Status

Community Health Network

Indianapolis, Indiana, United States

Site Status

Reid Hospital

Richmond, Indiana, United States

Site Status

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

Henry Ford Health Systems

Detroit, Michigan, United States

Site Status

Western Michigan University Homer Stryker Medical Center School of Medicine for Clinical Research

Kalamazoo, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

Michigan Heart

Ypsilanti, Michigan, United States

Site Status

Magnolia Regional

Corinth, Mississippi, United States

Site Status

Baptist Cardiovascular Surgery

Jackson, Mississippi, United States

Site Status

St. Peter's Health Partners

Albany, New York, United States

Site Status

Triad Cardiac & Thoracic Surgeons

Greensboro, North Carolina, United States

Site Status

Wake Medical

Raleigh, North Carolina, United States

Site Status

Coastal Thoracic Surgical Associates

Wilmington, North Carolina, United States

Site Status

Novant Health Cardiothoracic Surgeons

Winston-Salem, North Carolina, United States

Site Status

TriStar Cardiovascular Surgery

Nashville, Tennessee, United States

Site Status

Advanced Cardiovascular & Thoracic Surgery

Nashville, Tennessee, United States

Site Status

Cardiothoracic & Vascular Surgeons, PA

Austin, Texas, United States

Site Status

Cardiothoracic Associates

Corpus Christi, Texas, United States

Site Status

Tung H. Cai, MD, PA

Denton, Texas, United States

Site Status

KPS Cardiovascular Surgery

Shenandoah, Texas, United States

Site Status

Mountain Star Cardiovascular Services, LLC

Salt Lake City, Utah, United States

Site Status

Carilion Cardiothoracic Surgery

Roanoke, Virginia, United States

Site Status

Thoracic & Cardiovascular Associates, Inc.

Charleston, West Virginia, United States

Site Status

Countries

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United States

References

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Rego A, Cheung PC, Harris WJ, Brady KM, Newman J, Still R. Pericardial closure with extracellular matrix scaffold following cardiac surgery associated with a reduction of postoperative complications and 30-day hospital readmissions. J Cardiothorac Surg. 2019 Mar 15;14(1):61. doi: 10.1186/s13019-019-0871-5.

Reference Type DERIVED
PMID: 30876459 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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14-PR-1095

Identifier Type: -

Identifier Source: org_study_id

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