Early Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Boston Biomedical Associates
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Cardiovalve to be implanted without Major Device Related Adverse Events through 30 Days including:
- Status
- Terminated
- Last Updated
- last year
Overview
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 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.
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 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.
Investigators
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
Outcomes
Primary Outcomes
Cardiovalve to be implanted without Major Device Related Adverse Events through 30 Days including:
Time Frame: 30 Days
1. Death (Cardiovascular mortality vs non-cardiovascular); 2. Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications; 3. Disabling Stroke; 4. Myocardial infarction (MVARC definition); 5. Major access site and vascular complications 6. Fatal or Life-threatening bleeding (MVARC Type III- V) 7. Life-threatening arrhythmia; 8. Renal Failure requiring dialysis;
Cardiovalve Technical Success
Time Frame: 30 Days
1. Successful access, delivery and retrieval of the delivery system; and 2. Successful deployment and correct positioning of the first intended implant; and 3. Freedom from emergency surgery or reintervention related to the device or access procedure Without any procedural mortality, stroke, and device dysfunction (Central MR grade \> 1 or paravalvular leak moderate or severe, mean mitral gradient \> 6 mm Hg, LVOT obstruction (gradient increase ≥10 mm Hg)) at 30-day follow up.
Secondary Outcomes
- Change in LV end systolic volume index (LVESVI)(30 days, 3 months, 6 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score(30 days, 3 months, 6 months)
- 6-minute walk test (6MWT) distance(30 days, 3 months, 6 months)
- Clinical Frailty Score(30 days, 3 months, 6 months)
- Change in LV end diastolic volume index (LVEDVI)(30 days, 3 months, 6 months)
- Mitral Regurgitation severity(30 days, 3 months, 6 months)
- Changes in New York Heart Association (NYHA) functional class(30 days, 3 months, 6 months)