Clinical trial NCT03192813: Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II
Official title: Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II: A Randomized, Controlled, Non-inferiority Trial Evaluating Safety and Clinical Efficacy of the Symetis ACURATE Neo Compared to the Medtronic Evolut R Bioprosthesis in Transfemoral Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: Ceric Sàrl
Sponsor class: INDUSTRY
Collaborators: name: Symetis SA
First posted: 2017-06-20
Enrollment: 796
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of all-cause mortality or stroke rates
timeFrame: 1 year
Secondary outcomes:
measure: New permanent pacemaker rate
timeFrame: 30 days
measure: All cause mortality at 30 days
timeFrame: 30 days
measure: Stroke at 30 days
timeFrame: 30 days
measure: Valve malpositioning at 30 days
timeFrame: 30 days
measure: Peri-procedural myocardial infarction at 30 days
timeFrame: 30 days
measure: Cardiac Tamponade at 30 days
timeFrame: 30 days
measure: Implantation of multiple valves (TAV-in-TAV deployment) at 30 days
timeFrame: 30 days
measure: Annular rupture/dissection at 30 days
timeFrame: 30 days
measure: Left ventricular perforation at 30 days
timeFrame: 30 days
measure: Conversion to open heart surgery at 30 days
timeFrame: 30 days
measure: Intra-procedural mortality (during index procedure)
timeFrame: Procedurally
measure: Procedural mortality (up to 72 hours after procedure)
timeFrame: Procedurally and up to 72 hours post-procedurally
measure: Mortality (cardiac/non-cardiac) at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: All stroke (disabling/non disabling) at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: Composite of all-cause mortality or disabling stroke at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: Hospitalization for valve-related symptoms or worsened congestive heart at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: Life-threatening/major bleeding at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: Myocardial infarction at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: Valve related dysfunction requiring repeat procedure at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: Endocarditis at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: Valve thrombosis at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: New AV-conduction disturbances at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: New pacemaker implantation at 1 year
timeFrame: 1 year
measure: Any arrhythmia resulting in hemodynamic instability or requiring therapy at 30 days and 1 year
timeFrame: 30 days and 1 year
measure: VARC-2 combined endpoints at 30 days
timeFrame: 30 days
measure: Time-related valve safety at 1 year
timeFrame: 1 year
measure: Echocardiographic endpoint (1)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
measure: Echocardiographic endpoint (2)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
measure: Echocardiographic endpoint (3)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
measure: Echocardiographic endpoint (4)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
measure: Echocardiographic endpoint (5)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
measure: Echocardiographic endpoint (6)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
measure: Echocardiographic endpoint (7)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
measure: Echocardiographic endpoint (8)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
measure: Echocardiographic endpoint (9)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
measure: Echocardiographic endpoint (10)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
measure: Echocardiographic endpoint (11)
timeFrame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Heart Center, Rigshospitalet, University of Copenhagen
city: Brest
country: France
facility: CHRU Brest Cavale Blanche
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Massy
country: France
facility: Hôpital Jacques Cartier
city: Toulouse
country: France
facility: Clinique Pasteur
city: Aachen
country: Germany
facility: University Hospital Aachen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bernau bei Berlin
country: Germany
facility: Herzzentrum Brandenburg, Immanuel Klinikum Bernau
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital
city: Dresden
country: Germany
facility: Technische Universität Dresden
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen
city: Frankfurt
country: Germany
facility: Goethe-University Frankfurt
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig - Universitätsklinik
city: Munich
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
city: Munich
country: Germany
facility: Klinik für Herz- & Kreislauferkrankungen - Deutsches Herzzentrum München
city: Catania
country: Italy
facility: University of Catania, Ferrarotto Hospital
city: Rozzano- (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: San Donato
country: Italy
facility: IRCCS Policlinico San Donato
city: San Raffaele
country: Italy
facility: Ospedale San Raffaele
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
city: Brighton
country: United Kingdom
facility: Brighton and sussex University hospital NHS trust
state: England
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS TRUST
Study officials:
affiliation: Cardiology Division and Cardio-Thoracic & Vascular Department, Ferrarotto & Policlinico Hospitals, University of Catania, Italy
name: Corrado Tamburino, Prof, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany
name: Sabine Bleiziffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.