Status:
TERMINATED
Cardiovalve Transfemoral Mitral Valve System
Lead Sponsor:
Boston Biomedical Associates
Collaborating Sponsors:
Cardiovalve Ltd.
Cardiovascular Research Foundation, New York
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18-84 years
Phase:
NA
Brief Summary
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 th...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03813524
Start Date
March 26 2019
End Date
March 31 2020
Last Update
August 6 2024
Active Locations (2)
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1
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
2
Columbia University Medical Center/NYPH
New York, New York, United States, 10032