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Epicardial Infarct Repair Using CorMatrix®-ECM: Clinical Feasibility Study

NCT02887768 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-10-30

No results posted yet for this study

Summary

Epicardial Infarct Repair with CorMatrix-Extracellular Matrix (ECM) is an open-label, non-randomized, feasibility pilot study. Following ischemic injury the ECM of the heart adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and subsequent heart failure. Preclinical evidence demonstrates that epicardial infarct repair with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial performance. This study will interrogate epicardial infarct repair in patients undergoing coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial infarction as an adjunct to surgical revascularization. Patients will be evaluated for markers of cardiac function and left ventricular remodelling using cardiac magnetic resonance imaging (MRI). Adverse events will be monitored to ensure safety.

Conditions

Interventions

DEVICE

Epicardial Infarct Repair with CorMatrix-ECM

CorMatrix-ECM-biomaterial will be surgically applied to the epicardial surface of the infarct myocardium at the time of coronary artery bypass surgery

PROCEDURE

Coronary Artery Bypass Grafting Surgery

All participants will undergo standard coronary artery bypass grafting surgery to treat coronary artery disease

Sponsors & Collaborators

  • CorMatrix Cardiovascular, Inc.

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • Paul WM Fedak, MD, PhD · University of Calgary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-07-31
Completion
2017-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02887768 on ClinicalTrials.gov