Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation (MAVERIC)

MVRx, Inc.

Status: Unknown

Conditions: Mitral Valve Regurgitation

Treatments: Device: ARTO System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02302872

EU010513, AU220816

Details and patient eligibility

About

The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
2. Age ≥ 18
3. Trans-septal catheterization is determined to be feasible by the treating physician
4. NYHA class II-IV heart failure of any etiology
5. Symptomatic with MR grade ≥ 2+
6. LVEF ≥20% ≤ 50%
7. LVEDD > 50 mm and ≤ 70 mm
8. No anticipated change in patient's cardiac medication regimen anticipated throughout the course of the study.
9. • In the opinion of the investigator and heart surgery team, the patient is not a candidate for surgery, and the use of the ARTO™ System is technically feasible.

Exclusion criteria

1. 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
2. Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification)
3. Significant mitral annular calcification
4. Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
5. Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic valve or VAD
6. History of, or active, rheumatic heart disease
7. History of Atrial Septal Defects (ASD), whether repaired or not
8. History of previously repaired PFO or PFO associated with clinical symptoms (e.g., cerebral ischemia) within 6 months of the planned investigational procedure
9. In the opinion of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing
10. Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

ARTO system

Experimental group

Treatment:

Device: ARTO System