Trials / Completed
CompletedNCT02305602
A Study of VentriGel in Post-MI Patients
A Phase I, Open-label Study of the Effects of Percutaneous Administration of an Extracellular Matrix Hydrogel, VentriGel, Following Myocardial Infarction
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Ventrix, Inc. · Industry
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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 efficacy variables of ESV, EDV, EF, scar mass.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VentriGel | VentriGel will be injected via MyoStar catheter after NOGA mapping |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2018-09-05
- Completion
- 2019-06-01
- First posted
- 2014-12-02
- Last updated
- 2019-10-25
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02305602. Inclusion in this directory is not an endorsement.