Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
CorMatrix
ClinicalTrials.gov Identifier:
NCT02073331
First received: February 24, 2014
Last updated: July 25, 2016
Last verified: July 2016

February 24, 2014
July 25, 2016
March 2014
November 2016   (final data collection date for primary outcome measure)
The endpoint is defined as the proportion of subjects with device related adverse events. [ Time Frame: Initial post operative visit only ] [ Designated as safety issue: No ]
Data will be collected at the initial post-operative visit. This is a single visit study.
Same as current
Complete list of historical versions of study NCT02073331 on ClinicalTrials.gov Archive Site
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Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Subjects who have received CorMatrix ECM for pericardial reconstruction
Coronary Disease
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CorMatrix ECM
Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
5000
December 2016
November 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
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NCT02073331
14-PR-1095
No
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CorMatrix
CorMatrix
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Study Director: Andrew Green CorMatrix
CorMatrix
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP