AI-Powered Research

* Age > 18 years
* Moderate to severe functional MR
* Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including CRT if indicated.
* LVEF * 25%, LVEDD * 70mm
* Subject is high risk to undergo MV surgery (as assessed by a cardiac surgeon and a cardiologist at the site, and according to ESC/EACTS guidelines on the management of valvular heart disease)
* Transseptal catheterization and femoral vein access is determined to be feasible
* Subject is able and willing to give informed consent and follow protocol procedures

Exclusion Criteria

* Active bacterial endocarditis
* Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue
* Heavily calcified annulus or leaflets
* Subjects in whom transesophageal echocardiography is contraindicated
* Untreated clinically significant CAD requiring revascularization
* Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
* CVA or TIA within 6 months or severe carotid stenosis (>70% by Ultra sound)
* Renal insufficiency requiring dialysis
* Life expectancy of less than twelve months
* Patient is pregnant (urine HCG test result positive) or lactating
* Known sensitivity or allergy to Nickel or Chromium
* Known sensitivity or contraindication to procedural medications which cannot be adequately managed medically
* Bleeding or clotting disorders
* Subject is participating in concomitant research studies of investigational products
* Pulmonary hypertension >70mmHg at rest
* Mitral valve anatomy which may preclude proper device treatment
* Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>* Overall rate of Major Serious Adverse Events (SAEs)* and serious adverse<br /><br>device effects (SADE) until hospital discharge and at post-operative 30 days.<br /><br>* Death, myocardial infarction, cardiac tamponade, device related cardiac<br /><br>surgery, stroke<br /><br><br /><br>Performance<br /><br>* Technical success rate of the implantation of the Cardioband<br /><br>* Technical feasibility of Cardioband adjustment<br /><br>* Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure,<br /><br>at hospital discharge, and at 30 days. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>* Overall rate of Major Serious Adverse Events (SAEs) and serious adverse<br /><br>device effects (SADE) until 12 months<br /><br><br /><br>Performance:<br /><br>* MR Severity at 6 and 12 months<br /><br>* Change in 6 MWT in 6 and 12 months<br /><br>* Change in quality of life (MLHFQ) at 6 and 12 months*</p><br>