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

NCT03192813 | Completed

• 1 other identifier: SCOPE II
• Study Type: observational
• Target: 796
• Locations: 6 countries
• Sites: 23

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).

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (37)

• New permanent pacemaker rate

  30 days

• All cause mortality at 30 days

  30 days

• Stroke at 30 days

  30 days

• Valve malpositioning at 30 days

  30 days

• Peri-procedural myocardial infarction at 30 days

  30 days

Study Arms (2)

Symetis ACURATE neo™ transfemoral TAVI system

Patient assigned to this group will be implanted with Symetis ACURATE neo™ transfemoral TAVI system.

Device: Symetis ACURATE neo™ transfemoral 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.

Device: Medtronic CoreValve Evolut R TAVI System

Interventions

Symetis ACURATE neo™ transfemoral TAVI system DEVICE

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).

Symetis ACURATE neo™ transfemoral TAVI system

Medtronic CoreValve Evolut R TAVI System DEVICE

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).

Medtronic CoreValve Evolut R TAVI System

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

764 patients presenting with severe symptomatic aortic stenosis with the indication for TAVI, as agreed by the Heart Team. If all eligibility criteria and none of the exclusion criteria are fulfilled, patients will be allocated in a 1:1 ratio to either the Symetis ACURATE neo™ or the Medtronic CoreValve Evolut R (or any future CE-marked CoreValve versions) by permuted block randomization.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ceric Sàrl: lead
• Symetis SA: collaborator

Study Sites (23)

Heart Center, Rigshospitalet, University of Copenhagen

Copenhagen, DK-2100, Denmark

Location

CHRU Brest Cavale Blanche

Brest, 29200, France

Location

Centre Hospitalier Universitaire de Lille

Lille, 59037, France

Location

Hôpital Jacques Cartier

Massy, 91300, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

University Hospital Aachen

Aachen, 52074, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Herzzentrum Brandenburg, Immanuel Klinikum Bernau

Bernau bei Berlin, 16321, Germany

Location

St.-Johannes-Hospital

Dortmund, 44137, Germany

Location

Technische Universität Dresden

Dresden, 01307, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, 45138, Germany

Location

Goethe-University Frankfurt

Frankfurt, 60323, Germany

Location

Herzzentrum Leipzig - Universitätsklinik

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum München des Freistaates Bayern

Munich, 80636, Germany

Location

Klinik für Herz- & Kreislauferkrankungen - Deutsches Herzzentrum München

Munich, 80636, Germany

Location

University of Catania, Ferrarotto Hospital

Catania, 95124, Italy

Location

Istituto Clinico Humanitas

Rozzano- (MI), 20089, Italy

Location

IRCCS Policlinico San Donato

San Donato, 20097, Italy

Location

Ospedale San Raffaele

San Raffaele, 20132, Italy

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Brighton and sussex University hospital NHS trust

Brighton, England, BN25BE, United Kingdom

Location

The Leeds Teaching Hospitals NHS TRUST

Leeds, United Kingdom

Location

Related Publications (1)

• Tamburino C, Bleiziffer S, Thiele H, Scholtz S, Hildick-Smith D, Cunnington M, Wolf A, Barbanti M, Tchetche D, Garot P, Pagnotta P, Gilard M, Bedogni F, Van Belle E, Vasa-Nicotera M, Chieffo A, Deutsch O, Kempfert J, Sondergaard L, Butter C, Trillo-Nouche R, Lotfi S, Mollmann H, Joner M, Abdel-Wahab M, Bogaerts K, Hengstenberg C, Capodanno D. Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial. Circulation. 2020 Dec 22;142(25):2431-2442. doi: 10.1161/CIRCULATIONAHA.120.051547. Epub 2020 Oct 15.

  PMID: 33054367 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Corrado Tamburino, Prof, MD, PhD

  Cardiology Division and Cardio-Thoracic & Vascular Department, Ferrarotto & Policlinico Hospitals, University of Catania, Italy

  PRINCIPAL INVESTIGATOR

• Sabine Bleiziffer, MD

  Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: June 20, 2017
• Study Start: April 20, 2017
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); DE (11); GB (2); IT (4); DK (1); ES (1)