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OpenTrials
Completed

NCT Number: NCT02073331

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

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

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Proportion of Subjects With Device Related Adverse Events.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Elutia Inc.

Industry

Registry information

Official study title

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

Acronym: RECON

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2014
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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