Restore Myocardial Function With CorMatrix® ECM® Particulate (P-ECM)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
P-ECM Implant
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 to 75 years of age
- Ischemic cardiomyopathy with LVEF 25 to 40% as determined by resting cardiac echocardiography
- Subjects with severe chronic ischemic cardiomyopathy manifested by Canadian Cardiovascular Society (CCS) class II or greater angina, and/or New York Heart Association (NYHA) class II or greater dyspnea
- Patients who have undergone diagnostic coronary angiography demonstrating > 70% diameter narrowing of at least two major coronary arteries or branches OR > 50% diameter narrowing of the left main coronary artery
- Significant left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LVEF 25 to 40%) due to a prior myocardial infarction. This area of left ventricular dysfunction should be akinetic or severely hypokinetic, not aneurysmal, when assessed by echocardiography or LV angiogram
Exclusion Criteria:
- Need for urgent or emergent revascularization
- Patients with confirmed myocardial infarction within 14 days, and/or rising cardiac biomarker proteins (i.e., CK-MB or troponin), and/or worsening ECG changes
- Patient supported by balloon pump pre-op
- Moderate or severe (> 1+) aortic insufficiency as determined by echocardiogram
- History of severe ventricular tachyarrhythmias requiring treatment
- Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or congenital heart disease
- Prior cardiac operations
- Anticipated for concomitant surgical procedure at the time of CABG (e.g., valve repair or replacement, aneurysm resection, carotid endarterectomy, etc.)
- Active infection, with a temperature greater than 37.5°C and an unexplained white blood cell count in excess of 15,000/mm3 within 48 hours prior to surgery
- Hemoglobin less than 10g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
- Primary coagulopathy or platelet disorder, including thrombocytopenia with absolute platelet count < 80k or active state of disseminated intravascular coagulation
- Hemodynamically unstable patients, as defined by heart rate <40/min or >100/min, and/or systolic blood pressure <90 mmHg or >200 mmHg, and/or ongoing need for intravenous inotropic or vasopressor medications
- Severe pulmonary hypertension as defined by PVR > 8 Wood units, that is unresponsive to vasodilator therapy within 14 days of enrollment
- History of stroke or a history of cerebral vascular disease with significant (> 80%) extra cranial stenosis, without evidence of collateral flow. (Patients with cerebral vascular disease history must have acceptable stenosis documented by a carotid doppler study)
- Severe chronic renal insufficiency (serum creatinine >2.5mg/dl, estimated glomular filtration rate (eGFR) <35 mL/min/1.73m2 or need for dialysis)
- Evidence of intrinsic hepatic disease as defined as liver enzyme values (AST or ALT or total bilirubin) that are > 5 times the upper limit of normal within 30 days of enrollment (diagnosis of cirrhosis, chronic hepatitis), except in association with acute decompensation as determined by the Investigator
- Significant peripheral vascular disease defined by claudication, rest pain or leg ulceration
- Positive laboratory test results or a history of syphilis, Hepatitis B Virus, Hepatitis C Virus, Human T-Lymphotropic Virus Type 1 and 2, and Human Immunodeficiency Virus
- Active or known non-dermatological malignancy undergoing treatment including chemotherapy and radiotherapy or any other condition that would place the patient at increased risk for complications during the first 6 months after the procedure in the judgment of the attending cardiologist or cardiac surgeon
- Immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
- Previous solid organ transplantation or anticipated need for solid organ transplant other than heart (with the exception of corneal transplant)
- Hematological disorders (e.g., aplastic anemia) or bone marrow disorders
- Myelodysplastic syndrome
- Any condition associated with a life expectancy of less than 6 months
- Contraindications to magnetic resonance imaging (MRI) including presence of an implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM), or cases in which it is anticipated that an ICD or PPM will be implanted prior to the 6 month follow-up or claustrophobia (thus precluding performance of follow-up MRI scans)
- Contraindication to the administration of heparin, warfarin or anti-platelet agents
- Known allergic reaction or sensitivity to porcine material
- Significant cognitive impairment or psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study protocol
- Current participation or participation within the last 3 months in the study of an investigational drug, device, or biologic
Sites / Locations
- Central Clinical Hospital of the Ministry of the Interior in Warsaw
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
P-ECM Implant
Arm Description
P-ECM Implant into damaged ischemic and/or infarcted myocardium
Outcomes
Primary Outcome Measures
Subject-level incidence of serious adverse device effects (SADEs) or serious implantation procedure-related adverse events that occur within 6 months of implantation of the P-ECM
Secondary Outcome Measures
Full Information
NCT ID
NCT02139189
First Posted
May 13, 2014
Last Updated
July 18, 2017
Sponsor
CorMatrix Cardiovascular, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02139189
Brief Title
Restore Myocardial Function With CorMatrix® ECM® Particulate (P-ECM)
Official Title
RESTORE Myocardial Function With CorMatrix® ECM® Particulate (P-ECM) Implantation in Subjects With LVEF 25 to 40% Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CorMatrix Cardiovascular, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this CorMatrix P-ECM safety and feasibility study is to evaluate the safety and functional effect of the CorMatrix P-ECM.
Detailed Description
Evaluate the safety of the CorMatrix ECM Particulate (P-ECM) delivered trans-epicardially to subjects with left ventricular ejection fraction (LVEF) 25 to 40% during coronary artery bypass grafting (CABG)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P-ECM Implant
Arm Type
Experimental
Arm Description
P-ECM Implant into damaged ischemic and/or infarcted myocardium
Intervention Type
Device
Intervention Name(s)
P-ECM Implant
Intervention Description
P-ECM Implant into damaged ischemic and/or infarcted myocardium
Primary Outcome Measure Information:
Title
Subject-level incidence of serious adverse device effects (SADEs) or serious implantation procedure-related adverse events that occur within 6 months of implantation of the P-ECM
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 to 75 years of age
Ischemic cardiomyopathy with LVEF 25 to 40% as determined by resting cardiac echocardiography
Subjects with severe chronic ischemic cardiomyopathy manifested by Canadian Cardiovascular Society (CCS) class II or greater angina, and/or New York Heart Association (NYHA) class II or greater dyspnea
Patients who have undergone diagnostic coronary angiography demonstrating > 70% diameter narrowing of at least two major coronary arteries or branches OR > 50% diameter narrowing of the left main coronary artery
Significant left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LVEF 25 to 40%) due to a prior myocardial infarction. This area of left ventricular dysfunction should be akinetic or severely hypokinetic, not aneurysmal, when assessed by echocardiography or LV angiogram
Exclusion Criteria:
Need for urgent or emergent revascularization
Patients with confirmed myocardial infarction within 14 days, and/or rising cardiac biomarker proteins (i.e., CK-MB or troponin), and/or worsening ECG changes
Patient supported by balloon pump pre-op
Moderate or severe (> 1+) aortic insufficiency as determined by echocardiogram
History of severe ventricular tachyarrhythmias requiring treatment
Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or congenital heart disease
Prior cardiac operations
Anticipated for concomitant surgical procedure at the time of CABG (e.g., valve repair or replacement, aneurysm resection, carotid endarterectomy, etc.)
Active infection, with a temperature greater than 37.5°C and an unexplained white blood cell count in excess of 15,000/mm3 within 48 hours prior to surgery
Hemoglobin less than 10g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
Primary coagulopathy or platelet disorder, including thrombocytopenia with absolute platelet count < 80k or active state of disseminated intravascular coagulation
Hemodynamically unstable patients, as defined by heart rate <40/min or >100/min, and/or systolic blood pressure <90 mmHg or >200 mmHg, and/or ongoing need for intravenous inotropic or vasopressor medications
Severe pulmonary hypertension as defined by PVR > 8 Wood units, that is unresponsive to vasodilator therapy within 14 days of enrollment
History of stroke or a history of cerebral vascular disease with significant (> 80%) extra cranial stenosis, without evidence of collateral flow. (Patients with cerebral vascular disease history must have acceptable stenosis documented by a carotid doppler study)
Severe chronic renal insufficiency (serum creatinine >2.5mg/dl, estimated glomular filtration rate (eGFR) <35 mL/min/1.73m2 or need for dialysis)
Evidence of intrinsic hepatic disease as defined as liver enzyme values (AST or ALT or total bilirubin) that are > 5 times the upper limit of normal within 30 days of enrollment (diagnosis of cirrhosis, chronic hepatitis), except in association with acute decompensation as determined by the Investigator
Significant peripheral vascular disease defined by claudication, rest pain or leg ulceration
Positive laboratory test results or a history of syphilis, Hepatitis B Virus, Hepatitis C Virus, Human T-Lymphotropic Virus Type 1 and 2, and Human Immunodeficiency Virus
Active or known non-dermatological malignancy undergoing treatment including chemotherapy and radiotherapy or any other condition that would place the patient at increased risk for complications during the first 6 months after the procedure in the judgment of the attending cardiologist or cardiac surgeon
Immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
Previous solid organ transplantation or anticipated need for solid organ transplant other than heart (with the exception of corneal transplant)
Hematological disorders (e.g., aplastic anemia) or bone marrow disorders
Myelodysplastic syndrome
Any condition associated with a life expectancy of less than 6 months
Contraindications to magnetic resonance imaging (MRI) including presence of an implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM), or cases in which it is anticipated that an ICD or PPM will be implanted prior to the 6 month follow-up or claustrophobia (thus precluding performance of follow-up MRI scans)
Contraindication to the administration of heparin, warfarin or anti-platelet agents
Known allergic reaction or sensitivity to porcine material
Significant cognitive impairment or psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study protocol
Current participation or participation within the last 3 months in the study of an investigational drug, device, or biologic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Suwalski, Professor
Organizational Affiliation
Central Clinical Hospital of the Ministry of Interior in Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Clinical Hospital of the Ministry of the Interior in Warsaw
City
Warsaw
ZIP/Postal Code
02-507 Warsaw
Country
Poland
12. IPD Sharing Statement
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Restore Myocardial Function With CorMatrix® ECM® Particulate (P-ECM)
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