Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: Medtronic CoreValve Evolut R TAVI SystemDevice: Symetis ACURATE neo™ transfemoral TAVI system
- Registration Number
- NCT03192813
- Lead Sponsor
- Ceric Sàrl
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 796
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Medtronic CoreValve Evolut R TAVI System Medtronic CoreValve Evolut R TAVI System Patient assigned to this group will be implanted with Medtronic CoreValve Evolut R Transcatheter Aortic Valve Implantation (TAVI) System. Symetis ACURATE neo™ transfemoral TAVI system Symetis ACURATE neo™ transfemoral TAVI system Patient assigned to this group will be implanted with Symetis ACURATE neo™ transfemoral TAVI system.
- Primary Outcome Measures
Name Time Method Composite of all-cause mortality or stroke rates 1 year The primary objective is to compare the composite of all-cause mortality or stroke rates at 1 year (powered for non-inferiority).
- Secondary Outcome Measures
Name Time Method All cause mortality at 30 days 30 days All cause mortality
Annular rupture/dissection at 30 days 30 days - Annular rupture/dissection
Left ventricular perforation at 30 days 30 days - Left ventricular perforation
Stroke at 30 days 30 days Stroke
Cardiac Tamponade at 30 days 30 days Cardiac Tamponade
Valve malpositioning at 30 days 30 days Valve malpositioning
Implantation of multiple valves (TAV-in-TAV deployment) at 30 days 30 days Implantation of multiple valves (TAV-in-TAV deployment)
Conversion to open heart surgery at 30 days 30 days - Conversion to open heart surgery
Intra-procedural mortality (during index procedure) Procedurally - Intra-procedural mortality (during index procedure)
New permanent pacemaker rate 30 days The first secondary objective is to compare the new permanent pacemaker rate at 30 days (powered for superiority).
Peri-procedural myocardial infarction at 30 days 30 days Peri-procedural myocardial infarction
Myocardial infarction at 30 days and 1 year 30 days and 1 year - Myocardial infarction
Endocarditis at 30 days and 1 year 30 days and 1 year - Endocarditis
New pacemaker implantation at 1 year 1 year - New pacemaker implantation at 1 year
Any arrhythmia resulting in hemodynamic instability or requiring therapy at 30 days and 1 year 30 days and 1 year Any arrhythmia resulting in hemodynamic instability or requiring therapy
Echocardiographic endpoint (2) Post-procedurally [day 1 to 7], at 30 days, 1 year - Prosthetic aortic valve stenosis
Echocardiographic endpoint (3) Post-procedurally [day 1 to 7], at 30 days, 1 year - Patient prosthesis mismatch
Echocardiographic endpoint (4) Post-procedurally [day 1 to 7], at 30 days, 1 year - Aortic regurgitation (grading), proportion of more than mild regurgitation
Composite of all-cause mortality or disabling stroke at 30 days and 1 year 30 days and 1 year - Composite of all-cause mortality or disabling stroke
Valve related dysfunction requiring repeat procedure at 30 days and 1 year 30 days and 1 year - Valve related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)
Echocardiographic endpoint (7) Post-procedurally [day 1 to 7], at 30 days, 1 year - LV diastolic function
Echocardiographic endpoint (9) Post-procedurally [day 1 to 7], at 30 days, 1 year - Right ventricular (RV) dimension and function
Procedural mortality (up to 72 hours after procedure) Procedurally and up to 72 hours post-procedurally - Procedural mortality (up to 72 hours after procedure)
All stroke (disabling/non disabling) at 30 days and 1 year 30 days and 1 year - All stroke (disabling/non disabling)
Life-threatening/major bleeding at 30 days and 1 year 30 days and 1 year - Life-threatening/major bleeding (BARC 3b or more)
New AV-conduction disturbances at 30 days and 1 year 30 days and 1 year - New AV-conduction disturbances (LBBB only)
Echocardiographic endpoint (10) Post-procedurally [day 1 to 7], at 30 days, 1 year - Right atrial (RA) area
Mortality (cardiac/non-cardiac) at 30 days and 1 year 30 days and 1 year - Mortality (cardiac/non-cardiac)
Echocardiographic endpoint (11) Post-procedurally [day 1 to 7], at 30 days, 1 year - RV/RA-ratio and estimated systolic pulmonary arterial pressure
Hospitalization for valve-related symptoms or worsened congestive heart at 30 days and 1 year 30 days and 1 year - Hospitalization for valve-related symptoms or worsened congestive heart failure
Valve thrombosis at 30 days and 1 year 30 days and 1 year - Valve thrombosis
VARC-2 combined endpoints at 30 days 30 days Composite of device success, early safety, clinical efficacy and time-related valve safety
Time-related valve safety at 1 year 1 year Time-related valve safety
Echocardiographic endpoint (1) Post-procedurally [day 1 to 7], at 30 days, 1 year - Structural valve deterioration
Echocardiographic endpoint (6) Post-procedurally [day 1 to 7], at 30 days, 1 year - Systolic LV ejection fraction
Echocardiographic endpoint (5) Post-procedurally [day 1 to 7], at 30 days, 1 year - Intended valve performance: No prosthesis mismatch, mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, without moderate or severe prosthetic valve aortic regurgitation.
Echocardiographic endpoint (8) Post-procedurally [day 1 to 7], at 30 days, 1 year - Left atrial volume
Trial Locations
- Locations (23)
Elisabeth-Krankenhaus Essen
🇩🇪Essen, Germany
Deutsches Herzzentrum München des Freistaates Bayern
🇩🇪Munich, Germany
Istituto Clinico Humanitas
🇮🇹Rozzano- (MI), Italy
Complejo Hospitalario Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
The Leeds Teaching Hospitals NHS TRUST
🇬🇧Leeds, United Kingdom
St.-Johannes-Hospital
🇩🇪Dortmund, Germany
Technische Universität Dresden
🇩🇪Dresden, Germany
Klinik für Herz- & Kreislauferkrankungen - Deutsches Herzzentrum München
🇩🇪Munich, Germany
Goethe-University Frankfurt
🇩🇪Frankfurt, Germany
CHRU Brest Cavale Blanche
🇫🇷Brest, France
Hôpital Jacques Cartier
🇫🇷Massy, France
Centre Hospitalier Universitaire de Lille
🇫🇷Lille, France
Herz- und Diabeteszentrum NRW
🇩🇪Bad Oeynhausen, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
IRCCS Policlinico San Donato
🇮🇹San Donato, Italy
Clinique Pasteur
🇫🇷Toulouse, France
University Hospital Aachen
🇩🇪Aachen, Germany
Ospedale San Raffaele
🇮🇹San Raffaele, Italy
Herzzentrum Brandenburg, Immanuel Klinikum Bernau
🇩🇪Bernau bei Berlin, Germany
Herzzentrum Leipzig - Universitätsklinik
🇩🇪Leipzig, Germany
University of Catania, Ferrarotto Hospital
🇮🇹Catania, Italy
Brighton and sussex University hospital NHS trust
🇬🇧Brighton, England, United Kingdom
Heart Center, Rigshospitalet, University of Copenhagen
🇩🇰Copenhagen, Denmark