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

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ClinicalTrials.gov Identifier: NCT03192813
Recruitment Status : Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Symetis SA
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: Symetis ACURATE neo™ transfemoral TAVI system Device: Medtronic CoreValve Evolut R TAVI System

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.


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Study Type : Observational
Actual Enrollment : 796 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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 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
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).




Primary Outcome Measures :
  1. Composite of all-cause mortality or stroke rates [ Time Frame: 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 :
  1. New permanent pacemaker rate [ Time Frame: 30 days ]
    The first secondary objective is to compare the new permanent pacemaker rate at 30 days (powered for superiority).

  2. All cause mortality at 30 days [ Time Frame: 30 days ]
    All cause mortality

  3. Stroke at 30 days [ Time Frame: 30 days ]
    Stroke

  4. Valve malpositioning at 30 days [ Time Frame: 30 days ]
    Valve malpositioning

  5. Peri-procedural myocardial infarction at 30 days [ Time Frame: 30 days ]
    Peri-procedural myocardial infarction

  6. Cardiac Tamponade at 30 days [ Time Frame: 30 days ]
    Cardiac Tamponade

  7. Implantation of multiple valves (TAV-in-TAV deployment) at 30 days [ Time Frame: 30 days ]
    Implantation of multiple valves (TAV-in-TAV deployment)

  8. Annular rupture/dissection at 30 days [ Time Frame: 30 days ]
    - Annular rupture/dissection

  9. Left ventricular perforation at 30 days [ Time Frame: 30 days ]
    - Left ventricular perforation

  10. Conversion to open heart surgery at 30 days [ Time Frame: 30 days ]
    - Conversion to open heart surgery

  11. Intra-procedural mortality (during index procedure) [ Time Frame: Procedurally ]
    - Intra-procedural mortality (during index procedure)

  12. Procedural mortality (up to 72 hours after procedure) [ Time Frame: Procedurally and up to 72 hours post-procedurally ]
    - Procedural mortality (up to 72 hours after procedure)

  13. Mortality (cardiac/non-cardiac) at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Mortality (cardiac/non-cardiac)

  14. All stroke (disabling/non disabling) at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - All stroke (disabling/non disabling)

  15. Composite of all-cause mortality or disabling stroke at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Composite of all-cause mortality or disabling stroke

  16. Hospitalization for valve-related symptoms or worsened congestive heart at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Hospitalization for valve-related symptoms or worsened congestive heart failure

  17. Life-threatening/major bleeding at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Life-threatening/major bleeding (BARC 3b or more)

  18. Myocardial infarction at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Myocardial infarction

  19. Valve related dysfunction requiring repeat procedure at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Valve related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)

  20. Endocarditis at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Endocarditis

  21. Valve thrombosis at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Valve thrombosis

  22. New AV-conduction disturbances at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - New AV-conduction disturbances (LBBB only)

  23. New pacemaker implantation at 1 year [ Time Frame: 1 year ]
    - New pacemaker implantation at 1 year

  24. Any arrhythmia resulting in hemodynamic instability or requiring therapy at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    Any arrhythmia resulting in hemodynamic instability or requiring therapy

  25. VARC-2 combined endpoints at 30 days [ Time Frame: 30 days ]
    Composite of device success, early safety, clinical efficacy and time-related valve safety

  26. Time-related valve safety at 1 year [ Time Frame: 1 year ]
    Time-related valve safety

  27. Echocardiographic endpoint (1) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Structural valve deterioration

  28. Echocardiographic endpoint (2) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Prosthetic aortic valve stenosis

  29. Echocardiographic endpoint (3) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Patient prosthesis mismatch

  30. Echocardiographic endpoint (4) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Aortic regurgitation (grading), proportion of more than mild regurgitation

  31. Echocardiographic endpoint (5) [ Time Frame: 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.

  32. Echocardiographic endpoint (6) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Systolic LV ejection fraction

  33. Echocardiographic endpoint (7) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - LV diastolic function

  34. Echocardiographic endpoint (8) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Left atrial volume

  35. Echocardiographic endpoint (9) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Right ventricular (RV) dimension and function

  36. Echocardiographic endpoint (10) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Right atrial (RA) area

  37. Echocardiographic endpoint (11) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - RV/RA-ratio and estimated systolic pulmonary arterial pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192813


Locations
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Denmark
Heart Center, Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, DK-2100
France
CHRU Brest Cavale Blanche
Brest, France, 29200
Centre Hospitalier Universitaire de Lille
Lille, France, 59037
Hôpital Jacques Cartier
Massy, France, 91300
Clinique Pasteur
Toulouse, France, 31076
Germany
University Hospital Aachen
Aachen, Germany, 52074
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Herzzentrum Brandenburg, Immanuel Klinikum Bernau
Bernau bei Berlin, Germany, 16321
St.-Johannes-Hospital
Dortmund, Germany, 44137
Technische Universität Dresden
Dresden, Germany, 01307
Elisabeth-Krankenhaus Essen
Essen, Germany, 45138
Goethe-University Frankfurt
Frankfurt, Germany, 60323
Herzzentrum Leipzig - Universitätsklinik
Leipzig, Germany, 04289
Deutsches Herzzentrum München des Freistaates Bayern
Munich, Germany, 80636
Klinik für Herz- & Kreislauferkrankungen - Deutsches Herzzentrum München
Munich, Germany, 80636
Italy
University of Catania, Ferrarotto Hospital
Catania, Italy, 95124
Istituto Clinico Humanitas
Rozzano- (MI), Italy, 20089
IRCCS Policlinico San Donato
San Donato, Italy, 20097
Ospedale San Raffaele
San Raffaele, Italy, 20132
Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Spain, 15706
United Kingdom
Brighton and sussex University hospital NHS trust
Brighton, England, United Kingdom, BN25BE
The Leeds Teaching Hospitals NHS TRUST
Leeds, United Kingdom
Sponsors and Collaborators
Ceric Sàrl
Symetis SA
Investigators
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Principal Investigator: 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

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Responsible Party: Ceric Sàrl
ClinicalTrials.gov Identifier: NCT03192813     History of Changes
Other Study ID Numbers: SCOPE II
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction