Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
RECON
A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction
1 other identifier
observational
1,420
1 country
43
Brief Summary
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Typical duration for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2014
CompletedFirst Posted
Study publicly available on registry
February 27, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
October 4, 2019
CompletedJuly 21, 2023
July 1, 2023
3.8 years
February 24, 2014
June 26, 2019
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
CorMatrix ECM
Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
Eligibility Criteria
Subjects who have received CorMatrix ECM for pericardial reconstruction
You may qualify if:
- Subjects who have received CorMatrix ECM for pericardial reconstruction
- Sign an Informed Consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elutia Inc.lead
Study Sites (43)
Cario-Thoracic Surgeons, P.C.
Birmingham, Alabama, 35243, United States
Cardiovascular Consultants, LTD
Glendale, Arizona, 85308, United States
Phoenix Cardiac Surgery
Phoenix, Arizona, 85016, United States
Southwest Heart & Lung
Phoenix, Arizona, 85028, United States
University of Arizona Medical Center
Tucson, Arizona, 85724, United States
Mercy Clinic Cardiac Thoracic & Vascular Surgery
Fort Smith, Arkansas, 72903, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72205, United States
Baptist Medical Center
Little Rock, Arkansas, 72205, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Heart & Lung Surgical Specialties
Rancho Mirage, California, 92270, United States
Stockton Cardiothoracic Surgical Medical Group
Stockton, California, 95204, United States
Hartford Healthcare Medical Group
Hartford, Connecticut, 06106, United States
Tenet Florida Physician Services
Delray Beach, Florida, 33484, United States
South Florida Heart & Lung Institute
Doral, Florida, 33166, United States
Cardiothoracic & Vascular Surgical Associates
Jacksonville, Florida, 32207, United States
David L. Galbut, MD & Associates
Miami, Florida, 33137, United States
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, 33410, United States
Coastal Cardiovascular Surgeons
Panama City, Florida, 32401, United States
Southern Cardiac & Vascular Associates
Tallahassee, Florida, 32308, United States
Cardio Thoracic Vascular Surgery
Macon, Georgia, 31201, United States
Community Health Network
Indianapolis, Indiana, 46250, United States
Reid Hospital
Richmond, Indiana, 47374, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Henry Ford Health Systems
Detroit, Michigan, 48202, United States
Western Michigan University Homer Stryker Medical Center School of Medicine for Clinical Research
Kalamazoo, Michigan, 49048, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Magnolia Regional
Corinth, Mississippi, 38834, United States
Baptist Cardiovascular Surgery
Jackson, Mississippi, 39202, United States
St. Peter's Health Partners
Albany, New York, 12208, United States
Triad Cardiac & Thoracic Surgeons
Greensboro, North Carolina, 27401, United States
Wake Medical
Raleigh, North Carolina, 27610, United States
Coastal Thoracic Surgical Associates
Wilmington, North Carolina, 28401, United States
Novant Health Cardiothoracic Surgeons
Winston-Salem, North Carolina, 27104, United States
TriStar Cardiovascular Surgery
Nashville, Tennessee, 37203, United States
Advanced Cardiovascular & Thoracic Surgery
Nashville, Tennessee, 37207, United States
Cardiothoracic & Vascular Surgeons, PA
Austin, Texas, 78756, United States
Cardiothoracic Associates
Corpus Christi, Texas, 78404, United States
Tung H. Cai, MD, PA
Denton, Texas, 76210, United States
KPS Cardiovascular Surgery
Shenandoah, Texas, 77381, United States
Mountain Star Cardiovascular Services, LLC
Salt Lake City, Utah, 84124, United States
Carilion Cardiothoracic Surgery
Roanoke, Virginia, 24014, United States
Thoracic & Cardiovascular Associates, Inc.
Charleston, West Virginia, 25304, United States
Related Publications (1)
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.
PMID: 30876459DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Director
- Organization
- Aziyo Biologics, Inc.
Study Officials
- STUDY DIRECTOR
Andrew Green
Elutia Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2014
First Posted
February 27, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 21, 2023
Results First Posted
October 4, 2019
Record last verified: 2023-07