Cardiovalve Transfemoral Mitral Valve System
Cardiovalve Transfemoral Mitral Valve System
This study is to evaluate the safety and technical performance of the Cardiovalve
 Transfemoral Mitral Valve System with its associated procedure, to minimize 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 5 years.
The Cardiovalve offers a replacement valve delivered through a transfemoral access and
 transseptal approach, and is intended to reduce mortality and adverse event rates in selected
 patients for whom surgical options are not feasible.

 Innovation: A truly transfemoral, trans venous delivery of the valve which minimizes
 procedural risk. The Cardiovalve implant has a very low left ventricle (LV) protrusion
 footprint thus reducing the risk of LV outflow tract obstruction and/or interference with the
 LV. The experience to date is limited but thus far none of the clinical programs has been
 halted for safety reasons. Most of the technologies have focused on a transapical delivery
 approach (with mini-thoracotomy access) to further simplify the delivery method, with only a
 few allowing trans-septal delivery with femoral venous access.
Inclusion Criteria:

 -  85>Age ≥ 18 years

 -  Symptomatic (Stage D) severe MR confirmed by the echo core lab

 -  Cardiac Index > 2.0

 -  Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject
 enrollment based upon TTE)

 -  New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa

 -  Prior treatment with Guideline Directed Medical Therapy (GDMT) for heart failure for
 at least 30 days prior to index procedure

 -  Patient deemed a high surgical risk per MVARC definition by the site's Heart Team (as
 a minimum, one MV cardiac surgeon and one interventional cardiologist, and a cardiac
 imaging expert).

 Exclusion Criteria:

 -  MR etiology that is exclusively Primary (degenerative)

 -  Echocardiographic or angiographic evidence of severe mitral annular calcification

 -  Echocardiographic evidence of EROA < 0.3cm2

 -  Untreated clinically significant coronary artery disease requiring revascularization.

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

 -  Hypotension (systolic pressure < 90 mm Hg)/Cardiogenic shock or other hemodynamic
 instability requiring the need for inotropic

 -  Fixed pulmonary artery systolic pressure > 2/3 of systemic systolic blood pressure

 -  LVEDD >75 mm

 -  Severe tricuspid regurgitation or evidence of severe right ventricular dysfunction.

 -  Anatomy deemed not suitable for the Cardiovalve

 -  Elevated Creatine Kinase-MB (CK-MB)

 -  UNOS Status 1 heart transplant or prior orthotropic heart transplantation.

 -  Life Expectancy < 1 year due to non-cardiac conditions

 -  NYHA functional class IVb

 -  Chronic Kidney Disease with Creatinine clearance <30 ml/min/1.73m2

 -  Any prior mitral valve surgery or transcatheter mitral valve procedure

 -  Stroke or transient ischemic event within 30 Days prior to index procedure

 -  Modified Rankin Scale > 4 disability

 -  Class I indication for biventricular pacing (in patient with CRT device not implanted)

 -  Implant or revision of any rhythm management device (CRT or CRT-D) or implantable
 cardioverter-defibrillator within one month prior to index procedure

 -  Need for cardiovascular surgery (other than MV disease)

 -  Echocardiographic evidence of intracardiac mass, thrombus, or vegetation

 -  Active endocarditis

 -  Known severe symptomatic carotid stenosis (> 70 % via ultrasound)

 -  Active infections requiring current antibiotic therapy

 -  Active cancer with expected survival < one year

 -  Pregnant or planning pregnancy within next 12 months.

 -  Currently participating in an investigational drug or another device study

 -  Any condition making it unlikely the patient will be able to complete all procedures

 -  Patient (or legal guardian) unable or unwilling to provide written, informed consent
 before study enrollment

 -  Subjects in whom transesophageal echocardiography is contraindicated

 -  Known hypersensitivity or contraindication to procedural, post procedural medication
 (e.g., contrast solution, heparin, anticoagulation therapy) or hypersensitivity to
 nickel or titanium.