Status:
COMPLETED
A Study of VentriGel in Post-MI Patients
Lead Sponsor:
Ventrix, Inc.
Conditions:
Myocardial Infarction
Heart Failure
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
Brief Summary
This Phase I, open label, study will investigate the effects of VentriGel injection in patients who have experienced a first, large ST elevation myocardial infarction (STEMI) treated by PCI within the...
Detailed Description
Evaluate the safety and feasibility of VentriGel delivered trans-endocardially to subjects with left ventricular ejection fraction (LVEF) 25 to 45% secondary to MI. Secondary endpoints will look at ef...
Eligibility Criteria
Inclusion
- The subject is 30-75 years of age
- The subject must be able to provide informed consent
- At least 60 days and no more than 3 years will have passed since the first ST elevation myocardial infarction (Index STEMI) at time of VentriGel administration
- The Index STEMI must meet the following criteria:
- First time diagnosis of STEMI AND;
- Meet the STEMI criteria of the American College of Cardiology (ACC)/American Heart Association (AHA) (e.g. ST elevation in at least 2 contiguous leads \>0.2 mV in V1, V2 or V3 and/or \>0.1mV in at least two other leads), or new left bundle branch block (LBBB)
- Evidence of left ventricular remodeling secondary to the myocardial infarction using 2-D echocardiography or cMR;
- the LVEF must be ≥ 25% and ≤ 45% AND;
- The left ventricular wall thickness is ≥ 8 mm in target area.
- Successful percutaneous coronary intervention (PCI) restoring TIMI II of higher flow to infarcted area
- Negative pregnancy test \[serum human chorionic gonadotropin (βhCG)\] in women of childbearing potential within 24 hours prior to dosing) or if less than 2 years postmenopausal agree to use of adequate contraception during the study.
- Must be ambulatory, willing and able to comply with protocol, including follow-up visits
- Subject must be receiving best medical treatment for their post-MI clinical presentation according to the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines
- For those subjects indicated for heart failure medical therapy, subjects must be on stable therapy including beta-blockers and angiotensin converting enzyme inhibitors, if tolerated, for at least 45 days prior to therapy delivery
Exclusion
- Contraindications to cardiac MR
- NYHA Functional Classification 4 heart failure within the prior 6 months.
- Significant coronary artery stenosis that may require percutaneous or surgical revascularization within six months of enrollment, as determined by the principal investigator
- Left ventricular thrombus, left ventricular aneurysm, subjects with post-infarction pericarditis, or subjects with wall motion abnormalities outside the region of the infarct related artery
- Frequent, recurrent, sustained (\>30 seconds) ventricular tachycardia in 30 days prior to VentriGel administration
- ECG or 24 hour Holter Monitor with any of the following findings:
- Bifascicular block (left bundle branch block or right bundle branch block plus left hemi-block)
- Higher grade AV block (i.e. 3rd degree)
- Ventricular tachycardia (\>= 5 seconds of VT OR any symptomatic VT)
- Atrial fibrillation with heart rate greater than 110 bpm.
- Severe valvular disease (e.g. aortic stenosis of moderate or worse severity, valvular insufficiency requiring surgical repair) or history of heart valve replacement.
- Known allergy to porcine proteins or prior implantation of a porcine derived medical product including cardiac valves or other ECM products.
- Etiology of heart failure due to any cause (e.g. hypertrophic cardiomyopathies, restrictive cardiomyopathies, constrictive pericardial disease, amyloidosis, active myocarditis) other than the index MI.
- Severe peripheral vascular disease that impairs femoral arterial access.
- Less than 3 years, cancer free, since end of treatment for cancer (with exception of basal cell carcinoma)
- Alcohol or drug dependency within six months prior to enrollment
- Cerebrovascular event within the 90 days prior or major surgical procedure or major trauma within the 14 days prior to enrollment
- Participation, defined as receiving test article, in an experimental clinical study within 30 days prior to administration of VentriGel (i.e. screen failure from other study does not exclude subject)
- Uncontrolled hypertension defined as systolic blood pressure (SBP) \> 180 mmHg and/or or diastolic blood pressure (DBP) \>110 mmHg
- Abnormal laboratory values as defined below performed at screening:
- Aspartate aminotransferase \[AST\]/ alanine aminotransferase \[ALT\] ≥ 3 times upper limit of normal (ULN)
- Serum creatinine ≥ 2.0 mg/dL
- Platelet count \< 50,000/mm3
- Hemoglobin \< 9.0 g/dL
- HbA1c \> 9.0%
- PT or aPTT with clinically significant elevations relative to local laboratory norms
- Any other cardiac or non-cardiac conditions or illness which, in the opinion of the principal investigator, may place subjects at undue risk or compromise the objectives of the study.
- Institutional interpretation of cMR EF data outside the ≥ 25% and ≤ 45% limits
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02305602
Start Date
September 1 2015
End Date
June 1 2019
Last Update
October 25 2019
Active Locations (6)
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1
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of Florida
Gainesville, Florida, United States, 32606
4
Rush University Medical Center
Chicago, Illinois, United States, 60612