Clinical trial NCT02073331: Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
Official title: A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: Open heart surgery, cardiac repair
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 1420
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received CorMatrix ECM for pericardial reconstruction

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of Subjects With Device Related Adverse Events.
timeFrame: Post-op visit, after an average of 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cario-Thoracic Surgeons, P.C.
state: Alabama
city: Glendale
country: United States
facility: Cardiovascular Consultants, LTD
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiac Surgery
state: Arizona
city: Phoenix
country: United States
facility: Southwest Heart & Lung
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
city: Fort Smith
country: United States
facility: Mercy Clinic Cardiac Thoracic & Vascular Surgery
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Little Rock
country: United States
facility: Baptist Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Rancho Mirage
country: United States
facility: Heart & Lung Surgical Specialties
state: California
city: Stockton
country: United States
facility: Stockton Cardiothoracic Surgical Medical Group
state: California
city: Hartford
country: United States
facility: Hartford Healthcare Medical Group
state: Connecticut
city: Delray Beach
country: United States
facility: Tenet Florida Physician Services
state: Florida
city: Doral
country: United States
facility: South Florida Heart & Lung Institute
state: Florida
city: Jacksonville
country: United States
facility: Cardiothoracic & Vascular Surgical Associates
state: Florida
city: Miami
country: United States
facility: David L. Galbut, MD & Associates
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Gardens Medical Center
state: Florida
city: Panama City
country: United States
facility: Coastal Cardiovascular Surgeons
state: Florida
city: Tallahassee
country: United States
facility: Southern Cardiac & Vascular Associates
state: Florida
city: Macon
country: United States
facility: Cardio Thoracic Vascular Surgery
state: Georgia
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Richmond
country: United States
facility: Reid Hospital
state: Indiana
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: Kalamazoo
country: United States
facility: Western Michigan University Homer Stryker Medical Center School of Medicine for Clinical Research
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Corinth
country: United States
facility: Magnolia Regional
state: Mississippi
city: Jackson
country: United States
facility: Baptist Cardiovascular Surgery
state: Mississippi
city: Albany
country: United States
facility: St. Peter's Health Partners
state: New York
city: Greensboro
country: United States
facility: Triad Cardiac & Thoracic Surgeons
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical
state: North Carolina
city: Wilmington
country: United States
facility: Coastal Thoracic Surgical Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Cardiothoracic Surgeons
state: North Carolina
city: Nashville
country: United States
facility: TriStar Cardiovascular Surgery
state: Tennessee
city: Nashville
country: United States
facility: Advanced Cardiovascular & Thoracic Surgery
state: Tennessee
city: Austin
country: United States
facility: Cardiothoracic & Vascular Surgeons, PA
state: Texas
city: Corpus Christi
country: United States
facility: Cardiothoracic Associates
state: Texas
city: Denton
country: United States
facility: Tung H. Cai, MD, PA
state: Texas
city: Shenandoah
country: United States
facility: KPS Cardiovascular Surgery
state: Texas
city: Salt Lake City
country: United States
facility: Mountain Star Cardiovascular Services, LLC
state: Utah
city: Roanoke
country: United States
facility: Carilion Cardiothoracic Surgery
state: Virginia
city: Charleston
country: United States
facility: Thoracic & Cardiovascular Associates, Inc.
state: West Virginia
Study officials:
affiliation: Elutia Inc.
name: Andrew Green
role: STUDY_DIRECTOR
References:
citation: 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.