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

Completed

• Conditions: Coronary Disease

• Registration Number: NCT02073331
• Lead Sponsor: Aziyo Biologics, Inc.

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Study Start: 2014-03
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2019-06-26
• Results First Submitted QC: 2019-09-10
• Results First Posted: 2019-10-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1420

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With Device Related Adverse Events.	Post-op visit, after an average of 30 days	Data will be collected at the initial post-operative visit. This is a single visit study.

Trial Locations

Locations (42)

Cario-Thoracic Surgeons, P.C.; 🇺🇸 Birmingham, Alabama, United States

Cardiovascular Consultants, LTD; 🇺🇸 Glendale, Arizona, United States

Phoenix Cardiac Surgery; 🇺🇸 Phoenix, Arizona, United States

Southwest Heart & Lung; 🇺🇸 Phoenix, Arizona, United States

University of Arizona Medical Center; 🇺🇸 Tucson, Arizona, United States

Mercy Clinic Cardiac Thoracic & Vascular Surgery; 🇺🇸 Fort Smith, Arkansas, United States

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

Baptist Medical Center; 🇺🇸 Little Rock, Arkansas, United States

Heart & Lung Surgical Specialties; 🇺🇸 Rancho Mirage, California, United States

Stockton Cardiothoracic Surgical Medical Group; 🇺🇸 Stockton, California, United States

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