Cardiovalve Transfemoral System - FIM Study
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and
 transseptal approach and is intended for symptomatic patients with Mitral regurgitation for
 whom surgical options are not feasible.
The Cardiovalve system is a replacement valve delivered through a transfemoral access and
 transseptal approach and is intended for symptomatic patients with Mitral regurgitation for
 whom surgical options are not feasible.

 The purpose of this study is to evaluate the safety of the CardiovalveSystem with its
 associated procedure, and observe the device performance in reducing mitral regurgitation
 Data collected in this clinical study will include 30-day safety and performance of the
 device and delivery system, and long-term clinical outcomes over a follow-up of 2 years.
Inclusion Criteria:

 -  Age ≥ 18 years

 -  NYHA functional II, III or ambulatory IV

 -  Severe mitral regurgitation (MR grade 3-4+)

 -  High risk for conventional open mitral valve repair or replacement surgery in the
 consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and
 imaging specialist as a minimum)

 -  Able to undergo Transesophageal Echocardiography (TEE).

 -  Subject understands the study requirements and the treatment procedures and provides
 written Informed Consent before any study-specific tests or procedures are performed.

 -  The subject commits to return for the scheduled post-operative follow-up visits at the
 hospital.

 -  Suitable for femoral access procedure and transseptal catheterization

 -  Native mitral valve geometry and size and LV outflow tract characteristics compatible
 with the Cardiovalve

 Exclusion Criteria:

 -  Prior stroke or TIA within 3 months

 -  Acute myocardial infarction within the previous 30 days

 -  Any prior heart valve surgery or transcatheter mitral intervention

 -  Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid
 surgery within 30 days

 -  Rheumatic heart disease or endocarditis within the previous 3 months

 -  Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or
 any other structural heart disease causing heart failure other than dilated
 cardiomyopathy of either ischemic or non-ischemic etiology

 -  Existence of inferior vena cava filter or atrial septal device (contraindicating
 femoral access and transseptal catheterization)

 -  Untreated clinically significant coronary artery disease requiring revascularization

 -  Tricuspid valve disease requiring surgery or severe tricuspid regurgitation

 -  Aortic valve disease requiring surgery Anatomical Exclusion Criteria (assessed by
 pre-procedural imaging)

 -  Left Ventricular Ejection Fraction ( LVEF) <30%

 -  LV end diastolic diameter > 70mm

 -  Significant abnormalities of the mitral valve and sub-valvular apparatus.

 -  Severe mitral annular or leaflets calcification

 -  Left atrial or LV thrombus

 -  Severe right ventricular dysfunction

 -  Severe tricuspid or aortic valve disease General Exclusion Criteria

 -  Subject who is currently participating in an investigational study, other than this
 study

 -  Hemodynamic instability defined as systolic pressure < 90mmHg or the need for
 inotropic support or intra-aortic balloon pump or other hemodynamic support device, or
 any mechanical heart assistance

 -  Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated,
 has an allergy to Nitinol alloys (nickel and titanium), or has intolerance to
 antiplatelet, anticoagulant, or thrombolytic medications

 -  Bleeding diathesis or hypercoagulable state

 -  Active peptic ulcer or active gastrointestinal bleeding

 -  Pulmonary artery systolic pressure >70 mmHg

 -  Patients with renal insufficiency (creatinine > 2.5 mg/dL)

 -  Subject with hepatic insufficiency

 -  Subject has a co-morbid illness that may result in a life expectancy of less than one
 year

 -  Active infection that requires antibiotic therapy

 -  Subject is pregnant, breastfeeding or intend to become pregnant within one year