AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System (AHEAD)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    30
  • sponsor
    Cardiovalve Ltd.
Updated on 3 March 2022
coronary artery disease
stroke
medical therapy
ejection fraction
regurgitation
heart failure
heart disease
myocardial infarction
cardiomyopathy
aortic valve disease
rheumatic
mitral valve repair
transesophageal echocardiography
cardiovascular surgery
mitral valve replacement
constrictive pericarditis
right ventricular dysfunction
tricuspid regurgitation
vena cava filter
tricuspid valve disease

Summary

This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation. Data collected in this clinical study will include 30-day safety and performance, and long-term clinical outcomes over a follow-up of 2 years.

Description

The Cardiovalve offers a mitral 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 trans femoral, trans venous delivery of the prosthetic mitral valve which minimizes procedural risk. The Cardiovalve Implant features a dual nitinol frame for robust radial strength with decoupling of the atrial flange and ventricular portion which contains 24 grasping legs designed for atraumatic anchoring of the device to the native mitral annulus. Valve leaflets are made of bovine pericardium. 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 Cardiovalve delivery system (DS) is designed for transfemoral delivery of the Implant with transseptal access to the left atrium. The catheter assembly is used to center the implant relative to the native mitral valve plane and align it with the left ventricual apex-to-base axis. After valve implantation, the delivery system is withdrawn.

Details
Condition Mitral Regurgitation, Mitral Valve Disease
Treatment Cardiovalve Transfemoral Mitral Valve
Clinical Study IdentifierNCT03339115
SponsorCardiovalve Ltd.
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
NYHA functional II, III or ambulatory IV
Severe mitral regurgitation (MR grade 3-4+)
Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated
Elevated risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities
Able to undergo Transesophageal Echocardiography (TEE)
Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
The subject commits to return for the scheduled post-operative follow-up visits at the hospital
Anatomical Inclusion Criteria
\. Suitable for femoral access procedure and trans septal catheterization
\. Native mitral valve geometry and size and LV outflow tract
characteristics compatible with the Cardiovalve (as assessed by the
independent Screening Committee)

Exclusion Criteria

Prior stroke or TIA within 3 months or Modified Rankin Scale 4 disability
Acute myocardial infarction within the previous 30 days
Any prior heart valve surgery or transcatheter mitral intervention
Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
Rheumatic heart disease or endocarditis within the previous 3 months
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
Untreated clinically significant coronary artery disease requiring revascularization
Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
Aortic or pulmonic valve disease requiring surgery
CRT/ICD implant within 30 days
Anatomical Exclusion Criteria (assessed by pre-procedural imaging)
\. Left Ventricular Ejection Fraction (LVEF) <30%
\. LV end diastolic diameter > 70mm
\. Significant abnormalities of the mitral valve and sub-valvular apparatus
\. Severe mitral annular or leaflets calcification
\. Left atrial or LV thrombus or vegetation
\. Severe right ventricular dysfunction
\. Severe tricuspid or aortic valve disease
General Exclusion Criteria
\. Subject who is currently participating in an investigational study, other
than this study
\. Hemodynamic instability defined as systolic pressure < 90mmHg or the need
for inotropic support or intra-aortic balloon pump or other hemodynamic
support device, or any mechanical heart assistance
\. Subject has contrast agent hypersensitivity that cannot be adequately
pre-medicated, has an allergy to Nitinol alloys (nickel and titanium), or has
intolerance to antiplatelet, anticoagulant, or thrombolytic medications
\. Bleeding diathesis or hypercoagulable state
\. Active peptic ulcer or active gastrointestinal bleeding
\. Pulmonary artery systolic pressure >70 mmHg
\. Patients with renal insufficiency (creatinine > 2.5 mg/dL)
\. Need for emergent or urgent surgery for any reason or any planned cardiac
Surgery within the next 12 months
\. Subject with hepatic insufficiency
\. Subject has a co-morbid illness that may result in a life expectancy of
less than one year
\. Active infection that requires antibiotic therapy
\. Subject is pregnant, breastfeeding or intend to become pregnant within
one year
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