Aortic Valve StenosisSCOPE IINCT03192813

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

An observational study of Aortic Valve Stenosis, run by Ceric Sàrl at 23 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 75 years and older
Conditions the study is for: Aortic Valve Stenosis
What is being tested?: Symetis ACURATE neo™ transfemoral TAVI system and Medtronic CoreValve Evolut R TAVI System
Type of treatment: Medical device
How many people: 796 participants
Where: 23 sitesin 6 countries
Study dates: 20 Apr 2017to 4 Jun 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 75 years and older
All sexes
No healthy volunteers
Older adult

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.

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

23 sites in 6 countries.

Country

City, postcode or hospital

23 sites in 6 countries

Germany11 sites

University Hospital Aachen
Aachen, 52074
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Deutsches Herzzentrum Berlin
Berlin, 13353
Herzzentrum Brandenburg, Immanuel Klinikum Bernau
Bernau bei Berlin, 16321
St.-Johannes-Hospital
Dortmund, 44137
Technische Universität Dresden
Dresden, 01307
Elisabeth-Krankenhaus Essen
Essen, 45138
Goethe-University Frankfurt
Frankfurt, 60323
Herzzentrum Leipzig - Universitätsklinik
Leipzig, 04289
Deutsches Herzzentrum München des Freistaates Bayern
Munich, 80636
Klinik für Herz- & Kreislauferkrankungen - Deutsches Herzzentrum München
Munich, 80636

Other trials in Germany

France4 sites

CHRU Brest Cavale Blanche
Brest, 29200
Centre Hospitalier Universitaire de Lille
Lille, 59037
Hôpital Jacques Cartier
Massy, 91300
Clinique Pasteur
Toulouse, 31076

Other trials in France

Italy4 sites

University of Catania, Ferrarotto Hospital
Catania, 95124
Istituto Clinico Humanitas
Rozzano- (MI), 20089
IRCCS Policlinico San Donato
San Donato, 20097
Ospedale San Raffaele
San Raffaele, 20132

Other trials in Italy

United Kingdom2 sites

Brighton and sussex University hospital NHS trust
Brighton, England, BN25BE
The Leeds Teaching Hospitals NHS TRUST
Leeds

Other trials in United Kingdom

Denmark1 site

Heart Center, Rigshospitalet, University of Copenhagen
Copenhagen, DK-2100

Other trials in Denmark

Spain1 site

Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, 15706

Other trials in Spain

About this study

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

Read the 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.

Conditions: Aortic Valve Stenosis
Being tested: Symetis ACURATE neo™ transfemoral TAVI system, Medtronic CoreValve Evolut R TAVI System
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Symetis ACURATE neo™ transfemoral TAVI systemDevice
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 SystemDevice
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 in NCT03192813
Study group	Role	What they receive
Symetis ACURATE neo™ transfemoral TAVI system		Patient assigned to this group will be implanted with Symetis ACURATE neo™ transfemoral TAVI system. Receives: 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. Receives: Device: Medtronic CoreValve Evolut R TAVI System

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 1 year

Secondary outcomes (37)

New permanent pacemaker rate
The first secondary objective is to compare the new permanent pacemaker rate at 30 days (powered for superiority).
Measured: 30 days
All cause mortality at 30 days
All cause mortality
Measured: 30 days
Stroke at 30 days
Stroke
Measured: 30 days
Valve malpositioning at 30 days
Valve malpositioning
Measured: 30 days
Peri-procedural myocardial infarction at 30 days
Peri-procedural myocardial infarction
Measured: 30 days
Cardiac Tamponade at 30 days
Cardiac Tamponade
Measured: 30 days
Implantation of multiple valves (TAV-in-TAV deployment) at 30 days
Implantation of multiple valves (TAV-in-TAV deployment)
Measured: 30 days
Annular rupture/dissection at 30 days
- Annular rupture/dissection
Measured: 30 days
Left ventricular perforation at 30 days
- Left ventricular perforation
Measured: 30 days
Conversion to open heart surgery at 30 days
- Conversion to open heart surgery
Measured: 30 days
Intra-procedural mortality (during index procedure)
- Intra-procedural mortality (during index procedure)
Measured: Procedurally
Procedural mortality (up to 72 hours after procedure)
- Procedural mortality (up to 72 hours after procedure)
Measured: Procedurally and up to 72 hours post-procedurally
Mortality (cardiac/non-cardiac) at 30 days and 1 year
- Mortality (cardiac/non-cardiac)
Measured: 30 days and 1 year
All stroke (disabling/non disabling) at 30 days and 1 year
- All stroke (disabling/non disabling)
Measured: 30 days and 1 year
Composite of all-cause mortality or disabling stroke at 30 days and 1 year
- Composite of all-cause mortality or disabling stroke
Measured: 30 days and 1 year
Hospitalization for valve-related symptoms or worsened congestive heart at 30 days and 1 year
- Hospitalization for valve-related symptoms or worsened congestive heart failure
Measured: 30 days and 1 year
Life-threatening/major bleeding at 30 days and 1 year
- Life-threatening/major bleeding (BARC 3b or more)
Measured: 30 days and 1 year
Myocardial infarction at 30 days and 1 year
- Myocardial infarction
Measured: 30 days and 1 year
Valve related dysfunction requiring repeat procedure at 30 days and 1 year
- Valve related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)
Measured: 30 days and 1 year
Endocarditis at 30 days and 1 year
- Endocarditis
Measured: 30 days and 1 year
Valve thrombosis at 30 days and 1 year
- Valve thrombosis
Measured: 30 days and 1 year
New AV-conduction disturbances at 30 days and 1 year
- New AV-conduction disturbances (LBBB only)
Measured: 30 days and 1 year
New pacemaker implantation at 1 year
- New pacemaker implantation at 1 year
Measured: 1 year
Any arrhythmia resulting in hemodynamic instability or requiring therapy at 30 days and 1 year
Any arrhythmia resulting in hemodynamic instability or requiring therapy
Measured: 30 days and 1 year
VARC-2 combined endpoints at 30 days
Composite of device success, early safety, clinical efficacy and time-related valve safety
Measured: 30 days
Time-related valve safety at 1 year
Time-related valve safety
Measured: 1 year
Echocardiographic endpoint (1)
- Structural valve deterioration
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (2)
- Prosthetic aortic valve stenosis
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (3)
- Patient prosthesis mismatch
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (4)
- Aortic regurgitation (grading), proportion of more than mild regurgitation
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (5)
- 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.
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (6)
- Systolic LV ejection fraction
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (7)
- LV diastolic function
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (8)
- Left atrial volume
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (9)
- Right ventricular (RV) dimension and function
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (10)
- Right atrial (RA) area
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (11)
- RV/RA-ratio and estimated systolic pulmonary arterial pressure
Measured: Post-procedurally [day 1 to 7], at 30 days, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 20174 Jun 2020

First posted20 Jun 2017
Study start20 Apr 2017
Primary completion4 Jun 2020
Study completion4 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
More trials run by Ceric SàrlThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 796 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03192813
Sponsor's protocol ID: SCOPE II
Acronym: SCOPE II
Status last verified: Jun 2020
First submitted: 30 Mar 2017
Last updated: 11 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33054367

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03192813
Acronym / sponsor ID: SCOPE II / SCOPE II
Conditions: Aortic Valve Stenosis
Study type: Observational
Recruitment status: Completed
Enrolment: 796 participants (actual)
Lead sponsor: Ceric SàrlIndustry (pharma, biotech, devices)
Collaborators: Symetis SA
Study start: 20 Apr 2017 (actual)
Primary completion: 4 Jun 2020 (actual)
Study completion: 4 Jun 2020 (actual)
First posted: 20 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Symetis ACURATE neo™ transfemoral TAVI system	–	Device: Symetis ACURATE neo™ transfemoral TAVI systemPatient assigned to this group will be implanted with Symetis ACURATE neo™ transfemoral TAVI system.
Medtronic CoreValve Evolut R TAVI System	–	Device: Medtronic CoreValve Evolut R TAVI SystemPatient assigned to this group will be implanted with Medtronic CoreValve Evolut R Transcatheter Aortic Valve Implantation (TAVI) System.

Who may qualify

Ages: 75 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
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.

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Symetis ACURATE neo™ transfemoral TAVI systemSymetis 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	Symetis ACURATE neo™ transfemoral TAVI system
Medtronic CoreValve Evolut R TAVI SystemMedtronic 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).	Device	Medtronic CoreValve Evolut R TAVI System

Primary outcome

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).

37 secondary outcomes

New permanent pacemaker rate
Time frame: 30 days
All cause mortality at 30 days
Time frame: 30 days
Stroke at 30 days
Time frame: 30 days
Valve malpositioning at 30 days
Time frame: 30 days
Peri-procedural myocardial infarction at 30 days
Time frame: 30 days
Cardiac Tamponade at 30 days
Time frame: 30 days
Implantation of multiple valves (TAV-in-TAV deployment) at 30 days
Time frame: 30 days
Annular rupture/dissection at 30 days
Time frame: 30 days
Left ventricular perforation at 30 days
Time frame: 30 days
Conversion to open heart surgery at 30 days
Time frame: 30 days
Intra-procedural mortality (during index procedure)
Time frame: Procedurally
Procedural mortality (up to 72 hours after procedure)
Time frame: Procedurally and up to 72 hours post-procedurally
Mortality (cardiac/non-cardiac) at 30 days and 1 year
Time frame: 30 days and 1 year
All stroke (disabling/non disabling) at 30 days and 1 year
Time frame: 30 days and 1 year
Composite of all-cause mortality or disabling stroke at 30 days and 1 year
Time frame: 30 days and 1 year
Hospitalization for valve-related symptoms or worsened congestive heart at 30 days and 1 year
Time frame: 30 days and 1 year
Life-threatening/major bleeding at 30 days and 1 year
Time frame: 30 days and 1 year
Myocardial infarction at 30 days and 1 year
Time frame: 30 days and 1 year
Valve related dysfunction requiring repeat procedure at 30 days and 1 year
Time frame: 30 days and 1 year
Endocarditis at 30 days and 1 year
Time frame: 30 days and 1 year
Valve thrombosis at 30 days and 1 year
Time frame: 30 days and 1 year
New AV-conduction disturbances at 30 days and 1 year
Time frame: 30 days and 1 year
New pacemaker implantation at 1 year
Time frame: 1 year
Any arrhythmia resulting in hemodynamic instability or requiring therapy at 30 days and 1 year
Time frame: 30 days and 1 year
VARC-2 combined endpoints at 30 days
Time frame: 30 days
Time-related valve safety at 1 year
Time frame: 1 year
Echocardiographic endpoint (1)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (2)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (3)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (4)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (5)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (6)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (7)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (8)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (9)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (10)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year
Echocardiographic endpoint (11)
Time frame: Post-procedurally [day 1 to 7], at 30 days, 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
Derived from this study: PubMed 33054367Tamburino 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Corrado Tamburino, Prof, MD, PhD principal investigator

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

Sabine Bleiziffer, MD principal investigator

Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany

23 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis, run by Ceric Sàrl at 23 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany, France, Italy, United Kingdom, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all-cause mortality or stroke rates (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03192813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.