NCT03311295
Terminated
Not Applicable
MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States
ConditionsMitral Valve Insufficiency
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Mvrx, Inc.
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Safety: Major Adverse Event Rate to 30 Days post-procedure
Overview
Brief Summary
The objective of the study is to evaluate the safety and feasibility of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Candidates must meet ALL of the following criteria to be enrolled in the study.
- •Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
- •Age 21-85, inclusive
- •Trans-septal catheterization is determined to be feasible by the treating physician
- •NYHA class II-IV heart failure of any etiology
- •Symptomatic with MR grade ≥ 2+
- •LVEF \< 40%
- •LVEDD \> 50 mm and ≤ 75 mm
- •No anticipated change in patient's cardiac medication regimen anticipated throughout the course of the study.
- •In the opinion of the investigator and heart surgery team, the patient is not an appropriate candidate for surgery, and the use of the ARTO System is technically feasible
Exclusion Criteria
- •Candidates will be excluded from enrollment in the study if ANY of the following conditions apply.
- •In the opinion of the Investigator, the femoral vein and internal jugular vein cannot accommodate a 16 F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present
- •Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification)
- •Significant mitral annular calcification
- •Hemodynamic instability (systolic pressure \< 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
- •Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic valve or VAD
- •History of, or active, rheumatic heart disease
- •History of Atrial Septal Defects (ASD), whether repaired or not
- •History of previously repaired PFO or PFO associated with clinical symptoms (e.g., cerebral ischemia) within 6 months of the planned investigational procedure
- •In the opinion of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing
Outcomes
Primary Outcomes
Safety: Major Adverse Event Rate to 30 Days post-procedure
Time Frame: 30 days post procedure
Major Adverse Events (MAEs) will be categorized and defined in accordance with the relation to the procedure and device.
Efficacy: Mitral regurgitation grade by ASE criteria and change from baseline to 1 year
Time Frame: Baseline to 1 year
Mitral regurgitation grade by ASE criteria and change from baseline to 1 year evaluated by 2-D transthoracic echocardiogram
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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