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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192813
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Symetis SA
Information provided by (Responsible Party):
Ceric Sàrl

Tracking Information
First Submitted Date March 30, 2017
First Posted Date June 20, 2017
Last Update Posted Date June 11, 2020
Actual Study Start Date April 20, 2017
Actual Primary Completion Date June 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2017)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 16, 2017)
  • 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).
  • All cause mortality at 30 days [ Time Frame: 30 days ]
    All cause mortality
  • Stroke at 30 days [ Time Frame: 30 days ]
    Stroke
  • Valve malpositioning at 30 days [ Time Frame: 30 days ]
    Valve malpositioning
  • Peri-procedural myocardial infarction at 30 days [ Time Frame: 30 days ]
    Peri-procedural myocardial infarction
  • Cardiac Tamponade at 30 days [ Time Frame: 30 days ]
    Cardiac Tamponade
  • Implantation of multiple valves (TAV-in-TAV deployment) at 30 days [ Time Frame: 30 days ]
    Implantation of multiple valves (TAV-in-TAV deployment)
  • Annular rupture/dissection at 30 days [ Time Frame: 30 days ]
    - Annular rupture/dissection
  • Left ventricular perforation at 30 days [ Time Frame: 30 days ]
    - Left ventricular perforation
  • Conversion to open heart surgery at 30 days [ Time Frame: 30 days ]
    - Conversion to open heart surgery
  • Intra-procedural mortality (during index procedure) [ Time Frame: Procedurally ]
    - Intra-procedural mortality (during index procedure)
  • 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)
  • Mortality (cardiac/non-cardiac) at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Mortality (cardiac/non-cardiac)
  • All stroke (disabling/non disabling) at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - All stroke (disabling/non disabling)
  • 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
  • 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
  • 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)
  • Myocardial infarction at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Myocardial infarction
  • 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)
  • Endocarditis at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Endocarditis
  • Valve thrombosis at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - Valve thrombosis
  • New AV-conduction disturbances at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
    - New AV-conduction disturbances (LBBB only)
  • New pacemaker implantation at 1 year [ Time Frame: 1 year ]
    - New pacemaker implantation at 1 year
  • 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
  • VARC-2 combined endpoints at 30 days [ Time Frame: 30 days ]
    Composite of device success, early safety, clinical efficacy and time-related valve safety
  • Time-related valve safety at 1 year [ Time Frame: 1 year ]
    Time-related valve safety
  • Echocardiographic endpoint (1) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Structural valve deterioration
  • Echocardiographic endpoint (2) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Prosthetic aortic valve stenosis
  • Echocardiographic endpoint (3) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Patient prosthesis mismatch
  • 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
  • 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.
  • Echocardiographic endpoint (6) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Systolic LV ejection fraction
  • Echocardiographic endpoint (7) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - LV diastolic function
  • Echocardiographic endpoint (8) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Left atrial volume
  • Echocardiographic endpoint (9) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Right ventricular (RV) dimension and function
  • Echocardiographic endpoint (10) [ Time Frame: Post-procedurally [day 1 to 7], at 30 days, 1 year ]
    - Right atrial (RA) area
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Aortic Valve Stenosis
Intervention
  • 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).
  • 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).
Study Groups/Cohorts
  • Symetis ACURATE neo™ transfemoral TAVI system
    Patient assigned to this group will be implanted with Symetis ACURATE neo™ transfemoral TAVI system.
    Intervention: 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.
    Intervention: Device: Medtronic CoreValve Evolut R TAVI System
Publications * Tamburino C, Bleiziffer S, Thiele H, Scholtz S, Hildick-Smith D, Cunnington M, Wolf A, Barbanti M, Tchetché D, Garot P, Pagnotta P, Gilard M, Bedogni F, Van Belle E, Vasa-Nicotera M, Chieffo A, Deutsch O, Kempfert J, Søndergaard L, Butter C, Trillo-Nouche R, Lotfi S, Möllmann 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: The SCOPE 2 Randomized Clinical Trial. Circulation. 2020 Oct 15. doi: 10.1161/CIRCULATIONAHA.120.051547. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 10, 2019)
796
Original Estimated Enrollment
 (submitted: June 16, 2017)
764
Actual Study Completion Date June 4, 2020
Actual Primary Completion Date June 4, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 75 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark,   France,   Germany,   Italy,   Spain,   United Kingdom
Removed Location Countries Finland
 
Administrative Information
NCT Number NCT03192813
Other Study ID Numbers SCOPE II
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ceric Sàrl
Study Sponsor Ceric Sàrl
Collaborators Symetis SA
Investigators
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
PRS Account Ceric Sàrl
Verification Date June 2020