Coronary DiseaseRECONNCT02073331

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

An observational study of Coronary Disease, run by Elutia Inc. at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Any age
Conditions the study is for: Coronary Disease
How many people: 1,420 participants
Where: 43 sitesUnited States
Study dates: Mar 2014to Dec 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Subjects who have received CorMatrix ECM for pericardial reconstruction

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

United States43 sites

St. Peter's Health Partners
Albany, New York, 12208
Cardiothoracic & Vascular Surgeons, PA
Austin, Texas, 78756
Cario-Thoracic Surgeons, P.C.
Birmingham, Alabama, 35243
Thoracic & Cardiovascular Associates, Inc.
Charleston, West Virginia, 25304
Magnolia Regional
Corinth, Mississippi, 38834
Cardiothoracic Associates
Corpus Christi, Texas, 78404
Tenet Florida Physician Services
Delray Beach, Florida, 33484
Tung H. Cai, MD, PA
Denton, Texas, 76210
Henry Ford Health Systems
Detroit, Michigan, 48202
South Florida Heart & Lung Institute
Doral, Florida, 33166
Mercy Clinic Cardiac Thoracic & Vascular Surgery
Fort Smith, Arkansas, 72903
Cardiovascular Consultants, LTD
Glendale, Arizona, 85308
Triad Cardiac & Thoracic Surgeons
Greensboro, North Carolina, 27401
Hartford Healthcare Medical Group
Hartford, Connecticut, 06106
Community Health Network
Indianapolis, Indiana, 46250
Baptist Cardiovascular Surgery
Jackson, Mississippi, 39202
Cardiothoracic & Vascular Surgical Associates
Jacksonville, Florida, 32207
Western Michigan University Homer Stryker Medical Center School of Medicine for Clinical Research
Kalamazoo, Michigan, 49048
Sparrow Hospital
Lansing, Michigan, 48912
Arkansas Heart Hospital
Little Rock, Arkansas, 72205
Baptist Medical Center
Little Rock, Arkansas, 72205
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Cardio Thoracic Vascular Surgery
Macon, Georgia, 31201
David L. Galbut, MD & Associates
Miami, Florida, 33137
TriStar Cardiovascular Surgery
Nashville, Tennessee, 37203
Advanced Cardiovascular & Thoracic Surgery
Nashville, Tennessee, 37207
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, 33410
Coastal Cardiovascular Surgeons
Panama City, Florida, 32401
Phoenix Cardiac Surgery
Phoenix, Arizona, 85016
Southwest Heart & Lung
Phoenix, Arizona, 85028
Wake Medical
Raleigh, North Carolina, 27610
Heart & Lung Surgical Specialties
Rancho Mirage, California, 92270
Reid Hospital
Richmond, Indiana, 47374
Carilion Cardiothoracic Surgery
Roanoke, Virginia, 24014
Mountain Star Cardiovascular Services, LLC
Salt Lake City, Utah, 84124
KPS Cardiovascular Surgery
Shenandoah, Texas, 77381
Baystate Medical Center
Springfield, Massachusetts, 01199
Stockton Cardiothoracic Surgical Medical Group
Stockton, California, 95204
Southern Cardiac & Vascular Associates
Tallahassee, Florida, 32308
University of Arizona Medical Center
Tucson, Arizona, 85724
Coastal Thoracic Surgical Associates
Wilmington, North Carolina, 28401
Novant Health Cardiothoracic Surgeons
Winston-Salem, North Carolina, 27104
Michigan Heart
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: 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.

Read the 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

Conditions: Coronary Disease
Keywords: Open heart surgery, cardiac repair
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02073331
Study group	Role	What they receive
CorMatrix ECM		Data collection for information on the use of CorMatrix ECM for pericardial reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Dec 2017

First posted27 Feb 2014 (estimated)
Study startMar 2014
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02073331
Sponsor's protocol ID: 14-PR-1095
Acronym: RECON
Status last verified: Jul 2023
First submitted: 24 Feb 2014
Last updated: 21 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 30876459

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction
ClinicalTrials.gov ID: NCT02073331
Acronym / sponsor ID: RECON / 14-PR-1095
Conditions: Coronary Disease
Keywords: Open heart surgery, cardiac repair
Study type: Observational
Recruitment status: Completed
Enrolment: 1,420 participants (actual)
Lead sponsor: Elutia Inc.Industry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 27 Feb 2014 (estimated)
Results: Posted 4 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
CorMatrix ECM	–	–Data collection for information on the use of CorMatrix ECM for pericardial reconstruction

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Subjects who have received CorMatrix ECM for pericardial reconstruction

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

Results and safety

Results posted to the registry on 4 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CorMatrix ECM	1,420	1,420

Primary outcome: Proportion of Subjects With Device Related Adverse Events.

Time frame: Post-op visit, after an average of 30 days. Number (95% Confidence Interval). Unit: Proportion of subjects

Measure	CorMatrix ECM n = 1,420
Value	0 (0 to 0)

Adverse events

Time frame: Data was collected through the subjects' first follow-up visit, which ranged from 0 to 229 days post-operatively.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CorMatrix ECM	0 of 1,420 (0%)	0 of 1,420 (0%)	8 of 1,420

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30876459Rego 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.

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Femoral Arterial Sheath Removal, Stress Ball
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Green study director

Elutia Inc.

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Disease, run by Elutia Inc. at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects With Device Related Adverse Events. (time frame: Post-op visit, after an average of 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02073331, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.