A Study of VentriGel in Post-MI Patients

NCT02305602 | Completed Phase 1 DMC

• 1 other identifier: CV-201
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

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 past 3 years and have evidence of left ventricular remodeling.

Conditions

Myocardial Infarction; Heart Failure; Left Ventricular Remodeling

Keywords

extracellular matrix

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse events that occur within 6 months of injection

  6 months

Study Arms (1)

Post Myocardial Infarction

EXPERIMENTAL

VentriGel will be injected via a MyoStar catheter after NOGA mapping in the 60 day to 3 year window since the first STEMI myocardial infarction

Biological: VentriGel

Interventions

VentriGel BIOLOGICAL

VentriGel will be injected via MyoStar catheter after NOGA mapping

Post Myocardial Infarction

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ventrix, Inc.: lead

Study Sites (6)

Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Florida

Gainesville, Florida, 32606, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Heart Failure; Ventricular Remodeling

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 2, 2014
• Study Start: September 1, 2015
• Primary Completion: September 5, 2018
• Study Completion: June 1, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

US (6)