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NCT02073331 Clinical Trial

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

Coronary Disease Clinical Trial

— RECON  

Official title:
A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02073331
Other study ID # 14-PR-1095
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2014
Est. completion date December 2017

Study information
Verified date July 2023
Source Aziyo Biologics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 1420
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Subjects who have received CorMatrix ECM for pericardial reconstruction - Sign an Informed Consent Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States St. Peter's Health Partners Albany New York
United States Cardiothoracic & Vascular Surgeons, PA Austin Texas
United States Cario-Thoracic Surgeons, P.C. Birmingham Alabama
United States Thoracic & Cardiovascular Associates, Inc. Charleston West Virginia
United States Magnolia Regional Corinth Mississippi
United States Cardiothoracic Associates Corpus Christi Texas
United States Tenet Florida Physician Services Delray Beach Florida
United States Tung H. Cai, MD, PA Denton Texas
United States Henry Ford Health Systems Detroit Michigan
United States South Florida Heart & Lung Institute Doral Florida
United States Mercy Clinic Cardiac Thoracic & Vascular Surgery Fort Smith Arkansas
United States Cardiovascular Consultants, LTD Glendale Arizona
United States Triad Cardiac & Thoracic Surgeons Greensboro North Carolina
United States Hartford Healthcare Medical Group Hartford Connecticut
United States Community Health Network Indianapolis Indiana
United States Baptist Cardiovascular Surgery Jackson Mississippi
United States Cardiothoracic & Vascular Surgical Associates Jacksonville Florida
United States Western Michigan University Homer Stryker Medical Center School of Medicine for Clinical Research Kalamazoo Michigan
United States Sparrow Hospital Lansing Michigan
United States Arkansas Heart Hospital Little Rock Arkansas
United States Arkansas Heart Hospital Little Rock Arkansas
United States Baptist Medical Center Little Rock Arkansas
United States Cardio Thoracic Vascular Surgery Macon Georgia
United States David L. Galbut, MD & Associates Miami Florida
United States Advanced Cardiovascular & Thoracic Surgery Nashville Tennessee
United States TriStar Cardiovascular Surgery Nashville Tennessee
United States Palm Beach Gardens Medical Center Palm Beach Gardens Florida
United States Coastal Cardiovascular Surgeons Panama City Florida
United States Phoenix Cardiac Surgery Phoenix Arizona
United States Southwest Heart & Lung Phoenix Arizona
United States Wake Medical Raleigh North Carolina
United States Heart & Lung Surgical Specialties Rancho Mirage California
United States Reid Hospital Richmond Indiana
United States Carilion Cardiothoracic Surgery Roanoke Virginia
United States Mountain Star Cardiovascular Services, LLC Salt Lake City Utah
United States KPS Cardiovascular Surgery Shenandoah Texas
United States Baystate Medical Center Springfield Massachusetts
United States Stockton Cardiothoracic Surgical Medical Group Stockton California
United States Southern Cardiac & Vascular Associates Tallahassee Florida
United States University of Arizona Medical Center Tucson Arizona
United States Coastal Thoracic Surgical Associates Wilmington North Carolina
United States Novant Health Cardiothoracic Surgeons Winston-Salem North Carolina
United States Michigan Heart Ypsilanti Michigan

Sponsors (1)
Lead Sponsor Collaborator
Aziyo Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Subjects With Device Related Adverse Events. Data will be collected at the initial post-operative visit. This is a single visit study. Post-op visit, after an average of 30 days
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