Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation

Study Overview
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Brief Summary
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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).

Official Title
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Mitral Valve Repair Clinical Trial (MAVERIC Trial)

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: ARTO System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent Age ≥ 18 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 ≥20% ≤ 50% LVEDD > 50 mm and ≤ 70 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 a candidate for surgery, and the use of the ARTO™ System is technically feasible. Exclusion Criteria: 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 Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARTO system<br> | Device: ARTO System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event Rate to 30 Days post-procedure | Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure | <=30 days post procedure | 
| Mitral regurgitation grade and change from baseline to 30 days |  | <=30 days post procedure | 
| Device Technical Success | At exit from cath lab, alive, with Successful access, delivery and retrieval of the device delivery system, and Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure | procedural |