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

NCT03011346 | Completed

• 1 other identifier: V 4.0, 13.08.2018
• Study Type: interventional
• Target: 739
• Locations: 4 countries
• Sites: 20

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.

Conditions

Aortic Valve Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days

Secondary Outcomes (20)

• Device success

  30 days

• Early safety

  30 days

• Clinical efficacy

  30 days

• Time-related valve safety

  30 days, 1 year

• All-cause mortality

  30 days, 1 year, 3 years

Study Arms (2)

Symetis ACURATE neo/TF transfemoral TAVI system

ACTIVE COMPARATOR

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)

Device: Symetis ACURATE neo/TF transfemoral TAVI system

Edwards Sapien 3 Transcatheter Heart Valve

ACTIVE COMPARATOR

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)

Device: Edwards Sapien 3 Transcatheter Heart Valve

Interventions

Symetis ACURATE neo/TF transfemoral TAVI system DEVICE

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

Symetis ACURATE neo/TF transfemoral TAVI system

Edwards Sapien 3 Transcatheter Heart Valve DEVICE

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

Edwards Sapien 3 Transcatheter Heart Valve

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (20)

Herz- und Gefäss-Klinik GmbH Bad Neustadt

Bad Neustadt an der Saale, Bad Neustadt, 97616, Germany

Location

Klinkum Augsburg

Augsburg, 86156, Germany

Location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Herz- und Gefässzentrum Bad Beversen

Bad Bevensen, 29549, Germany

Location

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Herzzentrum Uniklinik Köln

Cologne, 50931, Germany

Location

St.-Johannes-Hospital

Dortmund, 44137, Germany

Location

Herzzentrum Dresden

Dresden, 01307, Germany

Location

Universitäres Herzzentrum Hamburg GmbH

Hamburg, 20251, Germany

Location

Städtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

ViDia Kliniken

Karlsruhe, 76135, Germany

Location

Klinik für Herzchirurgie Karlsruhe

Karlsruhe, 76185, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

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

Regensburg, 93053, Germany

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Bern University Hospital

Bern, 3010, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 31570258 RESULT

• Tomii D, Lanz J, Thiele H, Heg D, Kim WK, Joner M, Mollmann H, Burgdorf C, Linke A, Redwood S, Hilker M, Conradi L, Kerber S, Thilo C, Toggweiler S, Walther T, Prendergast B, Windecker S, Pilgrim T. Obstructive Coronary Artery Disease and Health Status in Transcatheter Aortic Valve Replacement: A Post Hoc Analysis of the SCOPE I Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2547111. doi: 10.1001/jamanetworkopen.2025.47111.

  PMID: 41364435 DERIVED

• Lanz J, Mollmann H, Kim WK, Burgdorf C, Linke A, Redwood S, Hilker M, Joner M, Thiele H, Conzelmann L, Conradi L, Kerber S, Thilo C, Toggweiler S, Prendergast B, Husser O, Stortecky S, Deckarm S, Kunzi A, Heg D, Walther T, Windecker S, Pilgrim T; SCOPE I Investigators. Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve. Circ Cardiovasc Interv. 2023 Jul;16(7):e012873. doi: 10.1161/CIRCINTERVENTIONS.123.012873. Epub 2023 Jul 7.

  PMID: 37417229 DERIVED

• 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.

  PMID: 33750210 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Thomas Pigrim, Prof. MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 5, 2017
• Study Start: February 8, 2017
• Primary Completion: May 2, 2019
• Study Completion: February 16, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); CH (3); NL (1); DE (15)