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Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis. (SCOPE I)

Primary Purpose

Aortic Valve Stenosis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Symetis ACURATE neo/TF transfemoral TAVI system

Edwards Sapien 3 Transcatheter Heart Valve

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic valve stenosis, Transcatheter aortic valve implantation, Transcatheter aortic valve replacement, Randomized controlled trial

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient with severe aortic stenosis defined by an aortic valve area (AVA) < 1cm2 or AVA indexed to body surface area (BSA) of < 0.6 cm2/m2, including low-flow severe aortic stenosis defined by stroke volume index (SVI) < 35ml/m2, as assessed by integration of echocardiographic and invasive measurements
Subject is symptomatic (heart failure symptoms with New York Heart Association (NYHA) Functional Class > I, angina or syncope)
Patient is considered at increased risk for mortality if undergoing conventional surgical aortic valve replacement or judged as not operable as determined either
- by a Logistic EuroSCORE > 20 % OR
- by a STS-PROM score > 10% OR
- by the heart team consisting of at least one cardiologist and cardiac surgeon based on the integration of individual clinical and anatomical factors not captured by risk-scores, the patient's age, frailty and life-expectancy
The heart team agrees on eligibility of the patient for participation and that TAVI by transfemoral access constitutes the most appropriate treatment modality, from which the patient will likely benefit most
Aortic annulus dimensions suitable for both valve types (area range: 338-573 mm2 AND perimeter range: 66-85 mm) based on ECG-gated multislice computed tomographic measurements. Findings of transesophageal echocardiography (TEE) and conventional aortography should be integrated in the anatomic assessment if available
Arterial aorto-iliac-femoral axis suitable for transfemoral access with a minimum access vessel diameter ≥ 6 mm as assessed by multislice computed tomographic angiography and/or conventional angiography
Written informed consent of the patient or her/his legal representative
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

Exclusion Criteria:

Non-valvular aortic stenosis
Congenital aortic stenosis or unicuspid or bicuspid aortic valve
Non-calcific acquired aortic stenosis
Anatomy not appropriate for transfemoral transcatheter aortic valve implantation due to size of the aortic annulus or degree or eccentricity of calcification of the native aortic valve or tortuosity of the aorta or ilio-femoral arteries
Emergency procedure including patients in cardiogenic shock (low cardiac output, vasopressor dependence, mechanical hemodynamic support)
Severely reduced left ventricular (LV) function (ejection fraction < 20%)
Pre-existing prosthetic heart valve in aortic position
Presence of mitral valve prosthesis
Concomitant planned procedure except for percutaneous coronary intervention (PCI)
Planned non-cardiac surgery within 30 days
Stroke within 30 days of the procedure.
Myocardial infarction within 30 days of the procedure (except type 2)
Evidence of intra-cardiac mass, thrombus or vegetation
Severe coagulation conditions
Inability to tolerate anticoagulation/anti-platelet therapy
Active bacterial endocarditis or other active infections
Hypertrophic cardiomyopathy with or without obstruction
Contraindication to contrast media or allergy to nitinol
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

Sites / Locations

Herz- und Gefäss-Klinik GmbH Bad Neustadt
Klinkum Augsburg
Zentralklinik Bad Berka
Herz- und Gefässzentrum Bad Beversen
Kerckhoff-Klinik
St.-Johannes-Hospital
Herzzentrum Dresden
Universitäres Herzzentrum Hamburg GmbH
Städtisches Klinikum Karlsruhe
ViDia Kliniken
Klinik für Herzchirurgie Karlsruhe
Herzzentrum Uniklinik Köln
Herzzentrum Leipzig
Deutsches Herzzentrum München
Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie
University Medical Center Utrecht
Bern University Hospital
Luzerner Kantonsspital
Universitätsspital Zürich
St Thomas' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Symetis ACURATE neo/TF transfemoral TAVI system

Edwards Sapien 3 Transcatheter Heart Valve

Arm Description

Symetis ACURATE neo/TF transfemoral TAVI system: self-expandable transcatheter aortic bioprosthesis, support frame made of nitinol, supra-annular processed trileaflet porcine pericardial valve and an outer skirt to mitigate paravalvular regurgitation (manufactured by Symetis SA, Ecublens, Switzerland)

Edwards SAPIEN 3 Transcatheter Heart Valve system: balloon-expandable transcatheter aortic bioprosthesis, support frame made of cobalt-chromium, three leaflets constructed of processed bovine pericardial tissue and an outer polyethylene terephthalate (PET) sealing cuff to mitigate paravalvular regurgitation (manufactured by Edwards Lifesciences, Inc., Irvine, California, USA)

Outcomes

Primary Outcome Measures

Modified* combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)

(* "NYHA class III or IV" is omitted due to lack of objectiveness in its ascertainment) All-cause mortality All stroke (disabling and non-disabling) Life-threatening or disabling bleeding Acute kidney injury (stage 2 or 3, including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, TAVI or SAVR in a separate intervention) Rehospitalization for valve-related symptoms or worsening congestive heart failure Valve-related dysfunction: prosthetic aortic valve stenosis (mean gradient ≥ 20 mmHg, effective orifice area ≤ 0.9-1.1cm2 and/or Doppler velocity index < 0.35) AND/OR ≥ moderate prosthetic valve regurgitation)

Secondary Outcome Measures

Device success

Combined endpoint composed of: Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation)

Early safety

Combined endpoint composed of: All-cause mortality All stroke (disabling and non-disabling) Life-threatening or disabling bleeding Acute kidney injury - stage 2 or 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, TAVI, or SAVR)

Clinical efficacy

Combined endpoint composed of: All-cause mortality All stroke (disabling and non-disabling) Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure NYHA class III or IV Valve-related dysfunction (mean aortic valve gradient ≥ 20 mmHg, effective orifice area (EOA) ≤ 0.9-1.1 cm2 and/or Doppler velocity index (DVI) < 0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)

Time-related valve safety

Combined endpoint composed of: Structural valve deterioration (Valve-related dysfunction (mean aortic valve gradient ≥ 20 mmHg, EOA ≤ 0.9-1.1 cm2 (depending on body surface area (BSA)) and/or DVI < 0.35 m/s AND/OR moderate or severe prosthetic valve regurgitation)) OR Requiring repeat procedure (TAVI or SAVR) Prosthetic valve endocarditis Prosthetic valve thrombosis Thrombo-embolic events (e.g. stroke) VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)

All-cause mortality

All stroke (disabling and non-disabling)

Life-threatening or disabling bleeding

Fatal bleeding (Bleeding Academic Research Consortium (BARC) type 5)OR Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR Bleeding causing hypovolaemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR Overt source of bleeding with drop in haemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units (BARC type 3b)

Acute kidney injury (stage 2 or 3, including renal replacement therapy)

Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline) OR Urine output <0.5 mL/kg/h for >12 but <24 h Stage 3: Increase in serum creatinine to ≥300% (>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR Urine output <0.3 ml/kg/h for ≥24 h OR Anuria for ≥12 h Notes: The increase in creatinine must occur within 48 h. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.

Coronary artery obstruction requiring intervention

Major vascular complication

Aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudo-aneurysm OR Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, haematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischaemia, or neurological impairment OR Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR Use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment OR Any new ipsilateral lower extremity ischaemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR Surgery for access site-related nerve injury OR Permanent access site-related nerve injury

Valve related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, TAVI or SAVR in a separate intervention)

Rehospitalization for valve-related symptoms or worsening congestive heart failure

Valve-related dysfunction: prosthetic aortic valve stenosis AND/OR ≥ moderate prosthetic valve regurgitation

Prosthetic aortic valve stenosis: mean gradient ≥ 20 mmHg, EOA ≤ 0.9-1.1cm2 and/or DVI < 0.35)

Conversion to open heart surgery

Annular rupture

New pacemaker implantation

Valve thrombosis

Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. Note that valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve-related should not be reported as valve thrombosis.

Mean trans-prosthetic aortic gradient

Aortic regurgitation

Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 score

Full Information

NCT ID

NCT03011346

First Posted

January 2, 2017

Last Updated

March 9, 2022

Sponsor

Insel Gruppe AG, University Hospital Bern

1. Study Identification

Unique Protocol Identification Number

NCT03011346

Brief Title

Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis.

Acronym

SCOPE I

Official Title

Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis for Transcatheter Aortic Valve Implantation by Transfemoral Approach.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 8, 2017 (Actual)

Primary Completion Date

May 2, 2019 (Actual)

Study Completion Date

February 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). Many novel devices are currently being developed and established transcatheter heart valves undergo design reiterations to address limitations and reduce complication rates associated with the device and implantation procedure. However, device comparisons by use of randomized trials are scarce in particular for newer generation transcatheter valves. The aim of this study is to assess non-inferiority of the self-expandable Symetis ACURATE neo/TF in comparison to the balloon-expandable Edwards SAPIEN 3 transcatheter aortic valve bioprosthesis with regard to early safety and clinical efficacy at 30 days.

Detailed Description

Background: Transcatheter aortic valve implantation (TAVI) is an established and valuable treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). The use of TAVI is rapidly expanding worldwide and the indications for TAVI are widening into lower risk populations in view of favorable outcomes among high and intermediate risk patients. Many novel devices are currently developed or established devices undergo design reiterations to address limitations, such as vascular access complications, paravalvular regurgitation, and atrio-ventricular conductance disturbances. However, device comparisons by use of randomized trials are scarce in particular for newer generation transcatheter valves. The Symetis ACURATE neo/TF, a self-expandable transcatheter valve delivered via transfemoral access, gained Conformité Européenne (CE) marking in September 2014 after showing favorable procedural and short term results. The SCOPE I trial will compare its performance to the balloon-expandable Edwards SAPIEN 3, a widely used and well-established transcatheter heart valve of the second generation, in a randomized fashion. Objectives: The primary objective is the comparison of the Symetis ACURATE neo/TF to the Edwards SAPIEN 3 transcatheter aortic bioprosthesis with regard to early safety and clinical efficacy at 30 days. Secondary objectives involve the comparison between the two devices with regard to secondary clinical and echocardiographic endpoints at 30 days, 1 year and 3 years. Methods: Sample Size: Based on an anticipated incidence proportion of 22% for the primary non-hierarchical composite endpoint at 30 days in both treatment arms, a non-inferiority margin of 7.7%, a power of 80%, a one-tailed significance level of α = 0.05, and a low attrition rate, the total required sample size amounts to 730 patients. Design: Patients will be allocated to the Symetis ACURATE neo/TF or the Edwards SAPIEN 3 bioprosthesis at a 1:1 ratio by means of a randomly permuted block randomisation stratified on study center and Society of Thoracic Surgeons' predicted risk of mortality score (STS-PROM) strata (< 3%, ≥ 3 to < 8%, ≥ 8%). Analysis: Estimates of the risk-differences between the two treatment arms with regard to the primary endpoint will be pooled over the predefined STS-PROM strata by means of the Cochran-Mantel-Haenszel method and Wald-type confidence limits will be calculated using the Sato variance estimator. The non-inferiority assumption will be tested at a one-sided significance level with a type I error rate (α) = 0.05. The analysis of the primary composite endpoint will be conducted according to the intention-to-treat (ITT) and the per protocol (PP) principle and non-inferiority should be claimed only if met by both. In case non-inferiority is established, a superiority analysis will be performed using a two-tailed significance level with a type I error rate of α = 0.05. Further secondary analyses will evaluate between group differences in relation to demographic, clinical, procedural, functional and imaging characteristics. Pre-specified subgroup analyses will be conducted by use of appropriate interaction tests contrasting categories of sex, STS-PROM score (< 3%, ≥ 3 to < 8%, ≥ 8%), left ventricular ejection fraction (< 50% vs. ≥ 50%), and native aortic valve eccentricity index (≤ 0.25 vs. > 0.25).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

Keywords

Aortic valve stenosis, Transcatheter aortic valve implantation, Transcatheter aortic valve replacement, Randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

739 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Symetis ACURATE neo/TF transfemoral TAVI system

Arm Type

Active Comparator

Arm Description

Arm Title

Edwards Sapien 3 Transcatheter Heart Valve

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Symetis ACURATE neo/TF transfemoral TAVI system

Intervention Description

Transcatheter aortic valve implantation of a Symetis ACURATE neo/TF bioprosthesis by transfemoral access, pre-dilatation mandatory.

Intervention Type

Device

Intervention Name(s)

Edwards Sapien 3 Transcatheter Heart Valve

Intervention Description

Transcatheter aortic valve implantation of an Edwards Sapien 3 bioprosthesis by transfemoral access.

Primary Outcome Measure Information:

Title

Modified* combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Device success

Description

Time Frame

30 days

Title

Early safety

Description

Time Frame

30 days

Title

Clinical efficacy

Description

Time Frame

30 days

Title

Time-related valve safety

Description

Time Frame

30 days, 1 year

Title

All-cause mortality

Time Frame

30 days, 1 year, 3 years

Title

All stroke (disabling and non-disabling)

Time Frame

30 days, 1 year, 3 years

Title

Life-threatening or disabling bleeding

Description

Time Frame

30 days, 1 year, 3 years

Title

Acute kidney injury (stage 2 or 3, including renal replacement therapy)

Description

Time Frame

30 days, 1 year, 3 years

Title

Coronary artery obstruction requiring intervention

Time Frame

30 days, 1 year, 3 years

Title

Major vascular complication

Description

Time Frame

30 days, 1 year, 3 years

Title

Valve related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, TAVI or SAVR in a separate intervention)

Time Frame

30 days, 1 year, 3 years

Title

Rehospitalization for valve-related symptoms or worsening congestive heart failure

Time Frame

30 days, 1 year, 3 years

Title

Valve-related dysfunction: prosthetic aortic valve stenosis AND/OR ≥ moderate prosthetic valve regurgitation

Description

Prosthetic aortic valve stenosis: mean gradient ≥ 20 mmHg, EOA ≤ 0.9-1.1cm2 and/or DVI < 0.35)

Time Frame

30 days, 1 year, 3 years

Title

Conversion to open heart surgery

Time Frame

procedural

Title

Annular rupture

Time Frame

procedural

Title

New pacemaker implantation

Time Frame

30 days, 1 year, 3 years

Title

Valve thrombosis

Description

Time Frame

30 days, 1 year, 3 years

Title

Mean trans-prosthetic aortic gradient

Time Frame

30 days, 1 year, 3 years

Title

Aortic regurgitation

Time Frame

30 days, 1 year, 3 years

Title

Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 score

Time Frame

30 days, 1 year, 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient with severe aortic stenosis defined by an aortic valve area (AVA) < 1cm2 or AVA indexed to body surface area (BSA) of < 0.6 cm2/m2, including low-flow severe aortic stenosis defined by stroke volume index (SVI) < 35ml/m2, as assessed by integration of echocardiographic and invasive measurements Subject is symptomatic (heart failure symptoms with New York Heart Association (NYHA) Functional Class > I, angina or syncope) Patient is considered at increased risk for mortality if undergoing conventional surgical aortic valve replacement or judged as not operable as determined either by a Logistic EuroSCORE > 20 % OR by a STS-PROM score > 10% OR by the heart team consisting of at least one cardiologist and cardiac surgeon based on the integration of individual clinical and anatomical factors not captured by risk-scores, the patient's age, frailty and life-expectancy The heart team agrees on eligibility of the patient for participation and that TAVI by transfemoral access constitutes the most appropriate treatment modality, from which the patient will likely benefit most Aortic annulus dimensions suitable for both valve types (area range: 338-573 mm2 AND perimeter range: 66-85 mm) based on ECG-gated multislice computed tomographic measurements. Findings of transesophageal echocardiography (TEE) and conventional aortography should be integrated in the anatomic assessment if available Arterial aorto-iliac-femoral axis suitable for transfemoral access with a minimum access vessel diameter ≥ 6 mm as assessed by multislice computed tomographic angiography and/or conventional angiography Written informed consent of the patient or her/his legal representative 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 Exclusion Criteria: Non-valvular aortic stenosis Congenital aortic stenosis or unicuspid or bicuspid aortic valve Non-calcific acquired aortic stenosis Anatomy not appropriate for transfemoral transcatheter aortic valve implantation due to size of the aortic annulus or degree or eccentricity of calcification of the native aortic valve or tortuosity of the aorta or ilio-femoral arteries Emergency procedure including patients in cardiogenic shock (low cardiac output, vasopressor dependence, mechanical hemodynamic support) Severely reduced left ventricular (LV) function (ejection fraction < 20%) Pre-existing prosthetic heart valve in aortic position Presence of mitral valve prosthesis Concomitant planned procedure except for percutaneous coronary intervention (PCI) Planned non-cardiac surgery within 30 days Stroke within 30 days of the procedure. Myocardial infarction within 30 days of the procedure (except type 2) Evidence of intra-cardiac mass, thrombus or vegetation Severe coagulation conditions Inability to tolerate anticoagulation/anti-platelet therapy Active bacterial endocarditis or other active infections Hypertrophic cardiomyopathy with or without obstruction Contraindication to contrast media or allergy to nitinol 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Pigrim, Prof. MD

Organizational Affiliation

Bern University Hospital, Dep. of Cardiology, 3010 Bern, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herz- und Gefäss-Klinik GmbH Bad Neustadt

City

Bad Neustadt An Der Saale

State/Province

Bad Neustadt

ZIP/Postal Code

97616

Country

Germany

Facility Name

Klinkum Augsburg

City

Augsburg

ZIP/Postal Code

86156

Country

Germany

Facility Name

Zentralklinik Bad Berka

City

Bad Berka

ZIP/Postal Code

99437

Country

Germany

Facility Name

Herz- und Gefässzentrum Bad Beversen

City

Bad Bevensen

ZIP/Postal Code

29549

Country

Germany

Facility Name

Kerckhoff-Klinik

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

St.-Johannes-Hospital

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Herzzentrum Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitäres Herzzentrum Hamburg GmbH

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Städtisches Klinikum Karlsruhe

City

Karlsruhe

ZIP/Postal Code

76133

Country

Germany

Facility Name

ViDia Kliniken

City

Karlsruhe

ZIP/Postal Code

76135

Country

Germany

Facility Name

Klinik für Herzchirurgie Karlsruhe

City

Karlsruhe

ZIP/Postal Code

76185

Country

Germany

Facility Name

Herzzentrum Uniklinik Köln

City

Köln

ZIP/Postal Code

50931

Country

Germany

Facility Name

Herzzentrum Leipzig

City

Leipzig

ZIP/Postal Code

04289

Country

Germany

Facility Name

Deutsches Herzzentrum München

City

München

ZIP/Postal Code

80636

Country

Germany

Facility Name

Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

University Medical Center Utrecht

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Bern University Hospital

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Luzerner Kantonsspital

City

Luzern

ZIP/Postal Code

6000

Country

Switzerland

Facility Name

Universitätsspital Zürich

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

St Thomas' Hospital

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31570258

Citation

Lanz J, Kim WK, Walther T, Burgdorf C, Mollmann H, Linke A, Redwood S, Thilo C, Hilker M, Joner M, Thiele H, Conzelmann L, Conradi L, Kerber S, Schymik G, Prendergast B, Husser O, Stortecky S, Heg D, Juni P, Windecker S, Pilgrim T; SCOPE I investigators. Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial. Lancet. 2019 Nov 2;394(10209):1619-1628. doi: 10.1016/S0140-6736(19)32220-2. Epub 2019 Sep 27.

Results Reference

result

PubMed Identifier

33750210

Citation

Kim WK, Walther T, Burgdorf C, Mollmann H, Linke A, Redwood S, Thilo C, Hilker M, Joner M, Thiele H, Conzelmann L, Conradi L, Kerber S, Schymik G, Prendergast B, Husser O, Blumenstein J, Stortecky S, Heg D, Kunzi A, Juni P, Windecker S, Pilgrim T, Lanz J; SCOPE I Investigators. One-Year Outcomes of a Randomized Trial Comparing a Self-Expanding With a Balloon-Expandable Transcatheter Aortic Valve. Circulation. 2021 Mar 23;143(12):1267-1269. doi: 10.1161/CIRCULATIONAHA.120.052251. Epub 2021 Mar 22. No abstract available.

Results Reference

derived

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Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis.

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