Cardiovalve Transfemoral Mitral Valve System (AHEAD)

Boston Biomedical Associates

Status

Terminated

Conditions

Mitral Regurgitation

Treatments

Device: Cardiovalve Transfemoral Mitral Valve

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03813524

CP 18-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

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.