REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary
 (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed
 on the beating heart through a transseptal approach. The Cardioband is deployed along the
 posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on
 the beating heart. A CE mark study with 30 subjects has been completed and documented
 reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in
 subjects with moderate to severe MR.

 Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure
 symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa),
 severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system
 in the post-marketing setting.
Inclusion Criteria:

 1. Age ≥18 years

 2. Severe (3+ to 4+) secondary Mitral Regurgitation

 3. Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical
 therapy including CRT if indicated

 4. The Local Site Heart Team concur that surgery will not be offered as a treatment
 option and that medical therapy is the intended therapy.

 5. Transfemoral access and transseptal deployment of the Cardioband is determined to be
 feasible

 6. Subject is willing and able to provide informed consent and follow protocol

 Exclusion Criteria:

 1. EF < 20%

 2. LVEDD ≥ 70 mm

 3. Heavily calcified annulus or leaflets

 4. Significant CAD requiring revascularization

 5. Active bacterial endocarditis

 6. Any percutaneous coronary, carotid, endovascular intervention or carotid surgery
 within 30 days or any coronary or endovascular surgery within 3 months

 7. Renal insufficiency requiring dialysis

 8. Life expectancy of less than twelve months

 9. Subject is participating in concomitant research studies of investigational products
 that have not reached their primary endpoint

 10. Pulmonary hypertension ≥ 70mmHg at rest

 11. Mitral valve anatomy which may preclude proper device treatment

 12. Right-sided congestive heart failure with echocardiographic evidence of severe right
 ventricular dysfunction and/or severe tricuspid regurgitation

 13. Severe liver disease

 14. Patient is pregnant or lactating

 15. Hypersensitivity to Nickel or Chromium

 16. Clinically significant bleeding diathesis or coagulopathy

 17. History of mitral valve repair

 18. TIA or CVA within 3 months