Cardiovalve Transfemoral Mitral Valve System

Launched by BOSTON BIOMEDICAL ASSOCIATES · Jan 18, 2019

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• 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.