Restore Myocardial Function With CorMatrix® ECM® Particulate (P-ECM)

NCT02139189 | Completed

• 1 other identifier: 13-PR-1083
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Study Arms (1)

P-ECM Implant

EXPERIMENTAL

P-ECM Implant into damaged ischemic and/or infarcted myocardium

Device: P-ECM Implant

Interventions

P-ECM Implant DEVICE

P-ECM Implant into damaged ischemic and/or infarcted myocardium

P-ECM Implant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Corvivo Cardiovascular, Inc.: lead

Study Sites (1)

Central Clinical Hospital of the Ministry of the Interior in Warsaw

Warsaw, 02-507 Warsaw, Poland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Piotr Suwalski, Professor

  Central Clinical Hospital of the Ministry of Interior in Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

PL (1)