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Heart FailureNCT02139189

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

A study testing P-ECM Implant in people with Heart Failure, run by Corvivo Cardiovascular, Inc. at 1 site in Poland.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Heart Failure
What is being tested?
P-ECM Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 sitePoland
Study dates
Jun 2014to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Central Clinical Hospital of the Ministry of the Interior in Warsaw

    Warsaw, 02-507 Warsaw

Other trials in Poland

About this study

Official title: RESTORE Myocardial Function With CorMatrix® ECM® Particulate (P-ECM) Implantation in Subjects With LVEF 25 to 40% Study

The purpose of this CorMatrix P-ECM safety and feasibility study is to evaluate the safety and functional effect of the CorMatrix P-ECM.

Read the 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)

Conditions
Heart Failure
Being tested
P-ECM Implant
Medical subject headings
Heart Failure

What participants receive

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

  • P-ECM ImplantDevice

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

Study groups in NCT02139189
Study groupRoleWhat they receive
P-ECM ImplantExperimentalP-ECM Implant into damaged ischemic and/or infarcted myocardium
Receives: Device: P-ECM Implant

What is being measured

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

  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

    Measured: 6 months

Timeline

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

  1. First posted15 May 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02139189
Sponsor's protocol ID
13-PR-1083
Status last verified
Jul 2017
First submitted
13 May 2014
Last updated
19 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing P-ECM Implant in people with Heart Failure, run by Corvivo Cardiovascular, Inc. at 1 site in Poland.

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 5 inclusion and 29 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 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). 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 NCT02139189.

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 19 Jul 2017.

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Clinical Trial NCT02139189 | AzTrials