Cardiovalve Transfemoral Mitral Valve System

Stopped early · Not applicable

Conditions studied: Mitral Regurgitation

In brief

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.

Key facts

Study ID

NCT03813524

Run by

Cardiovalve Ltd.

People needed

1

Starts

2019-03-26

Expected to finish

2020-03-31

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Piedmont Heart Institute — Atlanta, Georgia, United States
• Columbia University Medical Center/NYPH — New York, New York, United States

Full record on ClinicalTrials.gov

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