Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II

N/ACompletedNCT03192813

Ceric Sàrl796 enrolled

Overview

Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).

Transcatheter aortic valve implantation (TAVI) is an established and valuable treatment option for patients with severe symptomatic aortic stenosis and at high surgical risk for aortic valve replacement. The use of TAVI is rapidly expanding worldwide and its indications are widening into intermediate and lower risk populations. However, device comparisons by use of randomized trials are scarce in particular for newer generation transcatheter valves. The Symetis ACURATE neo™, a self-expanding transcatheter valve delivered via transfemoral access, is a second-generation device that gained CE mark approval in June 2014. The SCOPE-II trial will compare the safety and performance of the Symetis ACURATE neo™ with the self-expanding Medtronic Evolut R system, a widely used and well-established transcatheter heart valve, which obtained CE mark in 8NOV2006 and HAS approval on 13JAN2015.

Study Type

OBSERVATIONAL

Enrollment

796

Conditions

Aortic Valve Stenosis

Interventions

Symetis ACURATE neo™ transfemoral TAVI systemDEVICE

Symetis ACURATE neo™ transfemoral TAVI system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to mitigate paravalvular regurgitation (manufactured by Symetis SA, Ecublens, Switzerland).

Medtronic CoreValve Evolut R TAVI SystemDEVICE

Medtronic CoreValve Evolut R Transcatheter Aortic Valve Implantation (TAVI) System (or any future CE-marked Corevalve versions): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with severe symptomatic aortic stenosis defined by a mean aortic gradient \> 40 mmHg or peak jet velocity \> 4.0 m/s or an aortic valve area (AVA) \< 1cm2 or AVA indexed to body surface area (BSA) of \<0.6 cm2/m2 * Patient is symptomatic (heart failure with New York Heart Association (NYHA) Functional Class \> I, angina or syncope) * Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of a cardiologist and surgeon or as confirmed by a logistic EuroSCORE I \> 20% and / or STS score \> 10%. * Aortic annulus diameter ranging from 21 to 26mm and perimeter rage from 66 - 81.7mm , based on ECG-gated multi-slice computed tomographic measurements. Findings of TTE, TEE and conventional aortography should be integrated in the anatomic assessment. * Arterial aorto-iliac-femoral axis suitable for transfemoral access as assessed by conventional angiography and/or multi-detector computed tomographic angiography (access vessel diameter ≥ 6mm) * Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up * Patient age 75 years or older * Patient has given written consent to participate in the trial Exclusion Criteria: * Severely reduced left ventricular (LV) function (ejection fraction \<20%) * Pre-existing prosthetic heart valve in aortic and/or mitral position * Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol * Severe coagulation conditions * Inability to tolerate anticoagulation therapy * Contraindication to contrast media or allergy to nitinol * Active infection, including endocarditis * Congenital aortic stenosis or unicuspid or bicuspid aortic valve * Non-valvular aortic stenosis * Hypertrophic obstructive cardiomyopathy * New or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation * Non-calcific acquired aortic stenosis * Severe eccentricity of calcification * Anatomy not appropriate for transfemoral implant due to size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries * Severe mitral regurgitation

Locations (23)

Heart Center, Rigshospitalet, University of Copenhagen

Copenhagen, Denmark

Outcomes

Primary Outcomes

Composite of all-cause mortality or stroke rates

The primary objective is to compare the composite of all-cause mortality or stroke rates at 1 year (powered for non-inferiority).

Time frame: 1 year

Secondary Outcomes

New permanent pacemaker rate

The first secondary objective is to compare the new permanent pacemaker rate at 30 days (powered for superiority).

Time frame: 30 days

All cause mortality at 30 days

All cause mortality

Time frame: 30 days

Stroke at 30 days

Stroke

Time frame: 30 days

Valve malpositioning at 30 days

Valve malpositioning

Time frame: 30 days

Peri-procedural myocardial infarction at 30 days

Peri-procedural myocardial infarction

Time frame: 30 days

Cardiac Tamponade at 30 days

Cardiac Tamponade

Time frame: 30 days

Implantation of multiple valves (TAV-in-TAV deployment) at 30 days

Implantation of multiple valves (TAV-in-TAV deployment)

Time frame: 30 days

Annular rupture/dissection at 30 days

\- Annular rupture/dissection

Data from ClinicalTrials.gov

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CHRU Brest Cavale Blanche

Brest, France

Centre Hospitalier Universitaire de Lille

Lille, France

Hôpital Jacques Cartier

Massy, France

Clinique Pasteur

Toulouse, France

University Hospital Aachen

Aachen, Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Deutsches Herzzentrum Berlin

Berlin, Germany

Herzzentrum Brandenburg, Immanuel Klinikum Bernau

Bernau bei Berlin, Germany

St.-Johannes-Hospital

Dortmund, Germany

...and 13 more locations

Left ventricular perforation at 30 days

\- Left ventricular perforation

Time frame: 30 days

Conversion to open heart surgery at 30 days

\- Conversion to open heart surgery

Time frame: 30 days

Intra-procedural mortality (during index procedure)

\- Intra-procedural mortality (during index procedure)

Time frame: Procedurally

Procedural mortality (up to 72 hours after procedure)

\- Procedural mortality (up to 72 hours after procedure)

Time frame: Procedurally and up to 72 hours post-procedurally

Mortality (cardiac/non-cardiac) at 30 days and 1 year

\- Mortality (cardiac/non-cardiac)