Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation (MAVERIC)
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Major Adverse Event Rate to 30 Days post-procedure [ Time Frame: <=30 days post procedure ]
Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure
Mitral regurgitation grade and change from baseline to 30 days [ Time Frame: <=30 days post procedure ]
Device Technical Success [ Time Frame: procedural ]
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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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