Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients (START YOUNG)

May 7, 2026 updated by: Ceric Sàrl

Surgical Bioprosthesis Aortic Valve Replacement Vs. Myval Balloon-Expandable THV Series in Patients Aged 65 to 75 With Symptomatic Severe Aortic Stenosis Judged Eligible by Heart Team

The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.

Study Overview

Status

Recruiting

Conditions

Symptomatic Severe Aortic Stenosis

Intervention / Treatment

Detailed Description

Prospective, randomized, multinational, multicenter, open label, trial of 1180 patients treated with surgical bioprosthetic aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).

Study Type

Interventional

Enrollment (Estimated)

1180

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Philippe Garot, MD
Phone Number: +330160134602
Email: pgarot@angio-icps.com

Study Contact Backup

Name: Marie-Claude Morrice, MD
Email: mcmorice@cerc-europe.org

Study Locations

Austria
- - Graz, Austria, 8036
    - Recruiting
    - Medical University of Graz
    - Contact:
      
      Albrecht Schmidt, MD
      
      Phone Number: +436641436694
      
      Email: albrecht.schmidt@medunigraz.at
    - Contact:
      
      Birgit Zirngast, MD
      
      Phone Number: +436602144529
      
      Email: birgit.zirngast@medunigraz.at
  - Sankt Pölten, Austria, 3100
    - Recruiting
    - University Hostpital Sankt Pölten
    - Contact:
      
      Julia Mascherbauer, MD
      
      Phone Number: +436644272024
      
      Email: julia.mascherbauer@stpoelten.lknoe.at
    - Contact:
      
      Dominik Wiedemann, MD
      
      Phone Number: +432742900421400
      
      Email: Dominik.wiedemann@stpoelten.lknoe.at
  - Vienna, Austria, 1090
    - Recruiting
    - Medical University of Vienna
    - Contact:
      
      Philipp E Bartko, MD
      
      Phone Number: +4314040048590
      
      Email: philippemanuel.bartko@meduniwien.ac.at
    - Contact:
      
      Iuliana Coti, MD
      
      Phone Number: +4314040047031
      
      Email: iuliana.coti@meduniwien.ac.at
Estonia
- - Tallinn, Estonia, 13419
    - Recruiting
    - North-Estonia Medical Centre Foundation
    - Contact:
      
      Peep Laanmets, MD
      
      Phone Number: +37256616187
      
      Email: peep.laanmets@regionaalhaigla.ee
    - Contact:
      
      Gynter Taal, MD
      
      Phone Number: +37256608409
      
      Email: Gynter.taal@regionaalhaigla.ee
France
- - Lille, France
    - Recruiting
    - Chu Lille
    - Contact:
      
      Van Belle
      
      Phone Number: +33 3 20 44 53 01
      
      Email: eric.vanbelle@chu-lille.fr
  - Lyon, France
    - Recruiting
    - Infirmerie Protestante de Lyon
    - Contact:
      
      Esteve
      
      Phone Number: +33 6 48 15 82 67
      
      Email: dr.esteve@infirmerie-protestante.com
  - Massy, France
    - Recruiting
    - Massy-Hôpital Jacques Cartier
    - Contact:
      
      Garot
      
      Phone Number: + 33 1 60 13 46 02
      
      Email: pgarot@angio-icps.com
  - Rouen, France
    - Not yet recruiting
    - CHU de ROUEN
    - Contact:
      
      Eltchaninoff
      
      Phone Number: + 33 2 32 88 82 32
      
      Email: helene.eltchaninoff@chu-rouen.fr
  - Toulouse, France
    - Recruiting
    - Clinique Pasteur
    - Contact:
      
      Tchetche
      
      Phone Number: +33562211699
      
      Email: d.tchetche@clinique-pasteur.com
Germany
- - Frankfurt, Germany, 60596
    - Not yet recruiting
    - University Hospital Frankfurt
    - Contact:
      
      Philipp C. Seppelt, MD
      
      Phone Number: +4969630180397
      
      Email: Philipp.Seppelt@herz-frankfurt.de
    - Contact:
      
      Thomas Walther, MD
      
      Phone Number: +496963016141
      
      Email: Thomas.Walther@herz-frankfurt.de
  - Hamburg, Germany, 20246
    - Not yet recruiting
    - Universitatsklinikum Hamburg-Eppendorf
    - Contact:
      
      Nils Sörensen, MD
      
      Phone Number: +4915222815518
      
      Email: n.soerensen@uke.de
    - Contact:
      
      Andreas Schäfer, MD
      
      Email: and.schaefer@uke.de
  - München, Germany, 80636
    - Not yet recruiting
    - German Heart Munich
    - Contact:
      
      Magdalena Erlebach, MD
      
      Email: erlebach@dhm.mhn.de
    - Contact:
      
      Felix Wirth
      
      Phone Number: +498912182973
      
      Email: wirth@dhm.mhn.de
  - Trier, Germany, 54292
    - Not yet recruiting
    - Krankenhaus der Barmherzigen Bruder Trier
    - Contact:
      
      Nikos Werner, MD
      
      Phone Number: +496512082784
      
      Email: n.werner@bbtgruppe.de
    - Contact:
      
      Assad Haneya, MD
      
      Phone Number: +496512082751
      
      Email: a.haneya@bbtgruppe.de
Hungary
- - Budapest, Hungary
    - Not yet recruiting
    - Gottsegen National Cardiovascular Center
    - Contact:
      
      Peter Andreka, MD
      
      Phone Number: +36703820270
      
      Email: peter.andreka@gokvi.hu
    - Contact:
      
      Jeno Szolnoky, MD
      
      Phone Number: +36303991528
      
      Email: jeno.szolnoky@gokvi.hu
  - Debrecen, Hungary
    - Not yet recruiting
    - Department of Cardiology and Cardiac Surgery, University of Debrecen
    - Contact:
      
      Attila Béla Kertész, MD
      
      Phone Number: +36303996248
      
      Email: kertesz@med.unideb.hu
    - Contact:
      
      Tamás Szerafin, MD
      
      Phone Number: +36303905003
      
      Email: szerafin@hotmail.com
  - Szeged, Hungary
    - Not yet recruiting
    - University of Szeged
    - Contact:
      
      Zoltán Ruzsa, MD
      
      Phone Number: +36203338490
      
      Email: zruzsa25@gmail.com
    - Contact:
      
      Gábor Bari, MD
      
      Phone Number: +36203338490
      
      Email: drbarigabor@gmail.com
Italy
- - Mercogliano, Italy, 83013
    - Not yet recruiting
    - Montevergine Clinic
    - Contact:
      
      Luigi Salemme, MD
      
      Phone Number: +393493114639
      
      Email: lsalemme63@gmail.com
    - Contact:
      
      Carlo Zebele, MD
      
      Phone Number: +393392919314
      
      Email: carlo.zebele@gmail.com
  - Milan, Italy, 20157
    - Not yet recruiting
    - IRCCS Ospedale Galeazzi Sant'Ambrogio
    - Contact:
      
      Alfonso IELASI, MD
      
      Phone Number: +39 338 843 3189
      
      Email: alfonso.ielasi@gmail.com
    - Contact:
      
      Mattia Glauber, MD
      
      Phone Number: +39 348 393 1043
      
      Email: mattia.glauber@gmail.com
  - Milan, Italy
    - Not yet recruiting
    - Centro Cardiologico Monzino IRCCS
    - Contact:
      
      Federico De Marco, MD
      
      Phone Number: +393286242014
      
      Email: federico.demarco@gmail.com
    - Contact:
      
      Gianluca Polvani
  - Parma, Italy, 43126
    - Not yet recruiting
    - Azienda Ospedaliero-Universitaria Di Parma
    - Contact:
      
      Davide Capodanno, MD
      
      Email: dcapodanno@gmail.com
    - Contact:
      
      Salvatore Lentini, MD
      
      Email: eiko251961@gmail.com
  - Roma, Italy, 00128
    - Not yet recruiting
    - Fondazione Policlinico Campus Bio-Medico di Roma
    - Contact:
      
      Gian Paolo Ussia, MD
      
      Email: g.ussia@policlinicocampus.it
    - Contact:
      
      Raffaele Barbato, MD
      
      Email: m.chello@policlinicocampus.it
  - San Donato Milanese, Italy, 20097
    - Not yet recruiting
    - IRCCS Policlinico San Donato
    - Contact:
      
      Luca Testa, MD
      
      Phone Number: +393490808660
      
      Email: luctes@gmail.com
    - Contact:
      
      Carlo De Vincentiis, MD
      
      Phone Number: +390252774980
      
      Email: sgrcardiologiaclinica.PSD@grupposandonato.it
Poland
- - Poznan, Poland, 61848
    - Not yet recruiting
    - Poznan University Hospital
    - Contact:
      
      Marek Grygier, MD
      
      Phone Number: +48501066432
      
      Email: mgrygier@wp.pl
    - Contact:
      
      Marek Jemielity, MD
      
      Phone Number: +48618549210
      
      Email: mjemielity@poczta.onet.pl
  - Szczecin, Poland, 70111
    - Not yet recruiting
    - Pomorski Uniwersytet Medyczny w Szczecinie
    - Contact:
      
      Jaroslaw Goracy, MD
      
      Phone Number: +48600801616
      
      Email: jargo62@gmail.com
    - Contact:
      
      Piotr Pacholewicz, MD
  - Warsaw, Poland, 02097
    - Not yet recruiting
    - Medical Univeristy of Warsaw
    - Contact:
      
      Janusz Kochman, MD
      
      Phone Number: +48605051172
      
      Email: jkochman@wum.edu.pl
    - Contact:
      
      Radosław Wilimski, MD
      
      Phone Number: +48609510678
      
      Email: radoslaw.wilimski@wum.edu.pl
  - Warsaw, Poland, 04628
    - Not yet recruiting
    - National Institute of Cardiology
    - Contact:
      
      Adam Witkowski, MD
      
      Phone Number: +48223434127
      
      Email: witkowski@hbz.pl
    - Contact:
      
      Piotr Kołsut, MD
      
      Phone Number: +48223434610
      
      Email: pkolsut@ikard.pl
  - Warsaw, Poland
    - Not yet recruiting
    - Military Institute of Medicine in Warsaw
    - Contact:
      
      Piotr Kwiatkowski, MD
      
      Phone Number: +48606619195
      
      Email: pkwiatkowski@wim.mil.pl
    - Contact:
      
      Michal Zebala, MD
      
      Phone Number: +48600402994
      
      Email: kardiochirurgia@wim.mil.pl
  - Wroclaw, Poland, 50981
    - Not yet recruiting
    - Military Hospital in Wroclaw
    - Contact:
      
      Ściborski Krzysztof, MD
      
      Email: k.sciborski@4wsk.pl
    - Contact:
      
      Marek Mak, MD
      
      Phone Number: +48608367407
      
      Email: aureliuszm@tlen.pl
  - Wroclaw, Poland
    - Not yet recruiting
    - Provincial Specialist Hospital in Wroclaw
    - Contact:
      
      Marcin Protasiewicz, MD
      
      Email: mprot@poczta.onet.pl
    - Contact:
      
      Romuald Cichoń, MD
      
      Email: romuald.cichon@gmx.de
Portugal
- - Carnaxide, Portugal
    - Recruiting
    - Hospital de Santa Cruz, ULSLO
    - Contact:
      
      Rui Campante Teles, MD
      
      Phone Number: +351936097171
      
      Email: rcteles@outlook.com
    - Contact:
      
      Tiago Nolasco, MD
      
      Phone Number: +351917831100
      
      Email: tiagodnolasco@gmail.com
Romania
- - Bucharest, Romania
    - Not yet recruiting
    - Bucharest Clinical Emergency Hospital
    - Contact:
      
      Lucian Calmac, MD
      
      Phone Number: +40722742943
      
      Email: lcalmac@gmail.com
    - Contact:
      
      Horațiu Moldovan, MD
      
      Phone Number: +40729963785
      
      Email: h_moldovan@hotmail.com
  - Bucharest, Romania
    - Not yet recruiting
    - Central military emergency university hospital
    - Contact:
      
      Mohamed Khattab, MD
      
      Phone Number: +40720641142
      
      Email: moeran2003@yahoo.com
    - Contact:
      
      Liviu Stan, MD
      
      Phone Number: +40722320252
      
      Email: liviustan@gmail.com
  - Iași, Romania
    - Not yet recruiting
    - IBCV Iasi
    - Contact:
      
      Igor Nedelciuc, MD
      
      Phone Number: +40722742943
      
      Email: inedel@yahoo.com
    - Contact:
      
      Grigore Tinica, MD
      
      Phone Number: +40729963785
      
      Email: grigoretinica@yahoo.com
Serbia
- - Belgrade, Serbia
    - Not yet recruiting
    - University Clinical Center of Serbia
    - Contact:
      
      Zlatko Mehmedbegovic, MD
      
      Phone Number: +381606678761
      
      Email: zlatkombegovic@gmail.com
    - Contact:
      
      Svetozar Putnik, MD
      
      Phone Number: +381637234560
      
      Email: svetozar073@yahoo.com
  - Kamenitz, Serbia
    - Recruiting
    - Institute of Cardiovascular Diseases of Vojvodina
    - Contact:
      
      Mila Kovačević, MD
      
      Phone Number: +381601594444
      
      Email: milakov979@gmail.com
    - Contact:
      
      Lazar Velicki, MD
      
      Phone Number: +38163723456
      
      Email: lvelicki@gmail.com
Slovenia
- - Ljubljana, Slovenia, 1000
    - Recruiting
    - UKC Ljubljana
    - Contact:
      
      Matjaz Bunc, MD
      
      Phone Number: +38641757473
      
      Email: mbuncek@yahoo.com
    - Contact:
      
      Tadeja Kolar, MD
      
      Email: tkolar17@gmail.com
Spain
- - Valladolid, Spain
    - Recruiting
    - Hospital Clinico Universitario de Valladolid
    - Contact:
      
      Ignacio Amat Santos, MD
      
      Phone Number: +34 983420026
      
      Email: ijamat@gmail.com
- Principality of Asturias
  - Oviedo, Principality of Asturias, Spain, 33011
    - Recruiting
    - Hospital Universitario Central de Asturias
    - Contact:
      
      Pablo Avanzas, MD
      
      Phone Number: +34696476274
      
      Email: avanzas@secardiologia.es
    - Contact:
      
      Esther Villa
      
      Phone Number: +34616112327
      
      Email: fundacionasturcor@gmail.com
    - Principal Investigator:
      
      Jacobo Silva, MD
    - Principal Investigator:
      
      Pablo Avanzas, MD
Switzerland
- - Lausanne, Switzerland
    - Recruiting
    - CHUV
    - Contact:
      
      David Meier, MD
      
      Phone Number: +41 79 556 38 33
      
      Email: david.meier@chuv.ch
    - Contact:
      
      Matthias Kirsch
      
      Phone Number: +41 79 556 52 43
      
      Email: matthias.kirsch@chuv.ch
United Kingdom
- - Belfast, United Kingdom
    - Not yet recruiting
    - Royal Victoria Hospital
    - Contact:
      
      Colum Owens, MD
      
      Phone Number: +447749475293
      
      Email: Colum.owens@belfasttrust.hscni.net
    - Contact:
      
      Reuben Jeganathan, MD
      
      Phone Number: +44077762354590
      
      Email: Reuben.jeganathan@belfastrust.hscni.net
  - Brighton, United Kingdom
    - Recruiting
    - University Hospital Sussex NHS foundation Trust
    - Contact:
      
      David Hildick-Smith, MD
      
      Phone Number: +441273696955/I64049
      
      Email: david.hildick-smith@nhs.net
    - Contact:
      
      Uday Trivedi, MD
      
      Phone Number: +441273696955/64049
      
      Email: uday.trivedi@nhs.net
  - Cambridge, United Kingdom
    - Not yet recruiting
    - Royal Papworth Hospital
    - Contact:
      
      Charis Costopoulos, MD
      
      Email: charis.costopoulos@nhs.net
    - Contact:
      
      John Taghavi, MD
  - Cottingham, United Kingdom
    - Recruiting
    - Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
    - Contact:
      
      Raj Chelliah, MD
      
      Phone Number: +447748101796
      
      Email: g.mikhail@imperial.ac.uk
    - Contact:
      
      Emad Aljaaly, MD
      
      Phone Number: +447748101796
      
      Email: dumbor.ngaage@nhs.net
  - Coventry, United Kingdom
    - Recruiting
    - University Hospitals Coventry and Warwickshire NHS Trust
    - Contact:
      
      Nishant Gangil, MD
      
      Phone Number: +447469 316628
      
      Email: nishant.gangil@uhcw.nhs.uk
    - Contact:
      
      Tom Barker, MD
      
      Phone Number: +447469 316628
      
      Email: Tom.Barker@uhcw.nhs.uk
  - London, United Kingdom
    - Recruiting
    - Imperial College Healthcare NHS Trust
    - Contact:
      
      Ghada Mikhail, MD
      
      Phone Number: +447778809331
      
      Email: g.mikhail@imperial.ac.uk
    - Contact:
      
      Emad Aljaaly, MD
      
      Email: emad.aljaaly@nhs.net
  - London, United Kingdom
    - Recruiting
    - Barts Heart Centre
    - Contact:
      
      Mick Ozkor, MD
      
      Phone Number: +447590202577
      
      Email: mick.ozkor@nhs.net
    - Contact:
      
      Andreas Baumbach, MD
      
      Email: baumbach.andreas@nhs.net
  - Newcastle upon Tyne, United Kingdom
    - Not yet recruiting
    - Freeman Hospital
    - Contact:
      
      Mohamed Farag, MD
      
      Phone Number: +441912139920
      
      Email: mohamedfarag@nhs.net
    - Contact:
      
      Faruk Oezalp, MD
      
      Phone Number: +441912336161
      
      Email: faruk.oezalp1@nhs.net
  - Sheffield, United Kingdom
    - Not yet recruiting
    - Sheffield Teaching Hopitals NHS Foundation Trust
    - Contact:
      
      Javaid Iqbal, MD
      
      Phone Number: +447788438471
      
      Email: javaid.iqbal3@nhs.net
    - Contact:
      
      Norman Briffa, MD
      
      Phone Number: +441142714951
      
      Email: n.briffa@nhs.net
  - Swansea, United Kingdom
    - Recruiting
    - Morriston Hospital
    - Contact:
      
      Ayush Khurana, MD
      
      Phone Number: +447709363270
      
      Email: Colum.owens@belfasttrust.hscni.net
    - Contact:
      
      Fabio Falconieri, MD
      
      Phone Number: +447709363270
      
      Email: fabio.falconieri@wales.nhs.uk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participant will be included if all the following criteria are met:

Patients aged ≥65 and ≤75
Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity>4m/sec).
Patients with symptomatic heart disease due to severe native calcific aortic stenosis, as judged by a multidisciplinary heart team (including a cardiac surgeon), for whom SAVR or transfemoral TAVR is deemed feasible and approved by the local heart team.Signed informed consent for participation in the clinical investigation

Exclusion Criteria:

Participant will not be included if any one of the following conditions exists:

Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol
Life expectancy less than 1 year
Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.
Under judicial protection, tutorship, or curatorship
Participation in another trial before the primary endpoint

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAVR: Myval balloon-expandable THV Series Myval balloon-expandable THV Series will be used for valve replacement	Device: Myval balloon-expandable THV Series Patients receive Myval balloon-expandable THV Series (TAVR)
Active Comparator: SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site Surgical bioprosthetic valve commercially available at the clinical investigation site will be used for valve replacement	Device: Surgical bioprosthetic valve Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary safety endpoint at 1 month (non-inferiority): Composite measure of all-cause death, any stroke, bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or or reintervention for aortic valve dysfunction. Time Frame: 1 month post procedure	Composite measure of all-cause death, any stroke, VARC-3 type 1 (only overt bleeding that requires a transfusion of 1 unit of whole blood/red blood cells (BARC 3a), type 2 and 3 bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or reintervention for aortic valve dysfunction.	1 month post procedure
Primary efficacy endpoint at 1 year (non-inferiority): Composite measure of all-cause death, any stroke, or rehospitalization for valve related event Time Frame: 1 year post procedure	Composite measure of all-cause death, any stroke, or rehospitalization for valve related event at 1 year (VARC-3 definition)	1 year post procedure
CT Scan Sub Study endpoints: primary endpoint : prevalence of feasible redoTAVR or ViV TAVR without requiring leaflet modifications techniques (green cases). Time Frame: 1 month post procedure	Proportion of participants classified as "green cases" (redo-TAVR or ViV-TAVR feasible without leaflet modification) based on predefined CT scan criteria, including annular dimensions, coronary access, and valve frame interactions.	1 month post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint: Feasibility of re-TAVR based on CT scan evaluation (CT scan, for selected sites only) Time Frame: 1 month post procedure	Number of participants in whom redo-TAVR is deemed feasible based on CT scan evaluation. Feasibility will be assessed using predefined anatomical criteria, including: Annular dimensions Coronary access Valve frame interactions Need for leaflet modification techniques Feasibility will be categorized as: "Feasible without modification," "Feasible with modification," or "Not feasible.	1 month post procedure
Secondary Endpoint: Number of Participants Requiring New Permanent Pacemaker Implantation (PPI) Due to Conduction System Disturbances Time Frame: 1 month post procedure	Number of participants who require a new permanent pacemaker implantation (PPI) within 1 month post-procedure due to conduction system disturbances (e.g., high-degree atrioventricular block, left bundle branch block). Indications for PPI will be based on standard clinical guidelines.	1 month post procedure
Secondary Endpoint: Rate of prosthetic valve regurgitation (moderate or severe) Time Frame: 1 year post procedure		1 year post procedure
Secondary Endpoint: Number of Participants with Major Vascular Complications (VARC-3 Criteria) Time Frame: 1 month post procedure	Number of participants experiencing major vascular complications within 1 month post-procedure, as defined by VARC-3 criteria. o Scoring System: Valve Academic Research Consortium-3 (VARC-3) criteria o Definition: MAJOR vacular complication: One of the following: • Aortic dissection or aortic rupture • Vascular injury or compartment syndrome resulting in death,VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment • Distal embolization (non-cerebral) from a vascular source resulting in death, amputation, limb or visceral ischaemia, or irreversible end-organ damage • Unplanned endovascular or surgical intervention resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment • Closure device failure resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment	1 month post procedure
Secondary Endpoint: Performance of the aortic valve : Gradients (mean/max) assessed by TTE Time Frame: 1 year and 3 years post procedure	Mean and peak aortic valve gradients (mmHg) will be measured by transthoracic echocardiography (TTE) at each follow-up time point. Values will be reported as mean ± standard deviation (SD).	1 year and 3 years post procedure
Secondary Endpoint: Performance of the aortic valve : paravalvular leakage (PVL) grade evaluated by transthoracic echocardiogram (TTE) Time Frame: 1 year and 3 years post procedure	Number of participants stratified by paravalvular leakage (PVL) grade (None, Mild, Moderate, Severe), as assessed by TTE. PVL severity will be determined based on echocardiographic parameters defined by the VARC-3 criteria.	1 year and 3 years post procedure
Secondary Endpoint: Performance of the aortic valve : effective orifice are (EOA) evaluated by transthoracic echocardiogram (TTE) Time Frame: 1 year and 3 years post procedure	Effective orifice area (EOA) (cm²) measured using the continuity equation on TTE. Values will be reported as mean ± standard deviation (SD).	1 year and 3 years post procedure
CT Scan Sub Study endpoints: Secondary outcomes : feasibility of redoTAVR or ViV TAVR with or without requiring leaflet modification techniques Time Frame: 1 month post procedure	Proportion of participants in whom redo-TAVR or ViV-TAVR is feasible, with or without requiring leaflet modification techniques, based on CT scan evaluation. Classification will be based on predefined anatomic and hemodynamic feasibility criteria.	1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: prevalence of HALT in both TAVR and SAVR groups Time Frame: 1 month post procedure	Number of participants with HALT detected on CT scan in both TAVR and SAVR groups. HALT will be defined as the presence of hypo-attenuated leaflet thickening observed on post-procedure CT imaging.	1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Mean Transvalvular Gradient - Valve Hemodynamics Time Frame: 1 month post procedure	Outcome Measure: Mean change in mean transvalvular gradient (mmHg) in participants with and without HALT, measured by transthoracic echocardiography (TTE). Time Frame: 1 month post-procedure Unit of Measure: mmHg Interpretation: A higher mean transvalvular gradient suggests increased valve obstruction.	1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Peak Transvalvular Gradient - Valve Hemodynamics Time Frame: 1 month post procedure	Outcome Measure: Mean change in peak transvalvular gradient (mmHg) in participants with and without HALT, measured by transthoracic echocardiography (TTE). Time Frame: 1 month post-procedure Unit of Measure: mmHg Interpretation: A higher peak transvalvular gradient indicates greater hemodynamic burden on the valve.	1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Effective Orifice Area (EOA) - Valve Hemodynamics Time Frame: 1 month post procedure	Outcome Measure: Mean change in effective orifice area (cm²) in participants with and without HALT, measured by transthoracic echocardiography (TTE). Time Frame: 1 month post-procedure Unit of Measure: cm² Interpretation: A lower EOA suggests impaired valve opening and increased risk of stenosis.	1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Mean Transvalvular Gradient - THV Hemodynamics Time Frame: 1 month post procedure	Outcome Measure: Mean transvalvular gradient (mmHg) measured by TTE post-implantation. Time Frame: 1 month post-procedure Unit of Measure: mmHg Interpretation: Higher gradients indicate increased obstruction.	1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Peak Transvalvular Gradient - THV Hemodynamics Time Frame: 1 month post procedure	Outcome Measure: Peak transvalvular gradient (mmHg) measured by TTE post-implantation. Time Frame: 1 month post-procedure Unit of Measure: mmHg Interpretation: Higher peaks indicate more severe stenosis.	1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Effective Orifice Area (EOA) - THV Hemodynamics Time Frame: 1 month post procedure	Outcome Measure: Effective orifice area (cm²) measured by TTE post-implantation. Time Frame: 1 month post-procedure Unit of Measure: cm²	1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Commissural Alignment of THV Time Frame: 1 month post procedure	Mean commissural misalignment angle (degrees) measured by CT scan to evaluate THV positioning relative to native aortic valve commissures.	1 month post procedure
Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time Time Frame: 1, 2, 3, 4, 5, 7, 9, and 10 years	Number of participants who experience all-cause mortality at each follow-up time point.	1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time Time Frame: 1, 2, 3, 4, 5, 7, 9, and 10 years	Number of participants with any stroke (ischemic or hemorrhagic) as defined by clinical assessment and imaging confirmation.	1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Individual components of the primary endpoints: Bleeding Events (VARC-3 Type 1, 2, and 3) Over Time Time Frame: 1, 2, 3, 4, 5, 7, 9, and 10 years	Number of participants experiencing bleeding events classified as VARC-3 type 1 (BARC 3a), type 2 and 3. Scoring System: Valve Academic Research Consortium (VARC) scale: 1 Overt bleeding not requiringing surgical or percutaneous intervention, but requiring medical intervention, leading to hospitalization, an increased level of care, or medical evaluation Overt bleeding requiring a transfusion of 1 unit of whole blood/RBC 3 Overt bleeding in a critical organ, such as intracranial, intraspinal, intraocular, pericardial or intramuscular with compartment syndrome Overt bleeding causing hypovolemic shock or severe hypotension Overt bleeding requiring reoperation, surgical exploration, or re-intervention for the purpose of controlling bleeding Post-thoracotomy chest tube output ≥2 L within 24-h Overt bleeding requiring a transfusion of ≥5 units of whole blood/RBC Overt bleeding associated with a haemoglobin drop ≥5 g/dL Higher scores indicate worst outcomes	1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Individual components of the primary endpoints: Acute Kidney Injury (AKI) Stage 2-4 Over Time Time Frame: 1, 2, 3, 4, 5, 7, 9, and 10 years	Number of participants with acute kidney injury (AKI) stage 2-4 based on VARC-3 Scale Information: AKI from Valve Academic Research Consortium 3 (VARC-3): Scoring System: Stage 1: AKI that fulfils at least one of the following criteria: Increase in serum creatinine ≥150-200% (≥1.5-2.0x increase) within 7 days compared with baseline Increase of ≥ 0.3mg/dL (≥26.4 μmol/L) within 48 h of the index procedure o Stage 2: AKI that fulfils the following criterion: Increase in serum creatinine >200-300% (>2.0-3.0x increase) within 7 days compared with baseline o Stage 3: AKI that fulfils at least one of the following criteria: Increase in serum creatinine >300% (>3.0x increase) within 7 days compared with baseline Serum creatinine ≥4.0 mg/dL (≥354 μmol/L) with an acute increase of ≥0.5 mg/dL (≥44 μmol/L) Stage 4: AKI requiring new temporary or permanent renal replacement therapy Interpretation: Higher stages indicate more severe kidney injury	1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Individual components of the primary endpoints: Rehospitalization for Procedure-Related Event Over Time Time Frame: 1, 2, 3, 4, 5, 7, 9, and 10 years	Number of participants requiring rehospitalization due to procedure-related complications.	1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Individual components of the primary endpoints: Reintervention for Aortic Valve Dysfunction Over Time Time Frame: 1, 2, 3, 4, 5, 7, 9, and 10 years	Number of participants requiring reintervention (redo-TAVR, SAVR, or valve explantation) due to aortic valve dysfunction.	1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Number of Participants with Structural Valve Deterioration (VARC-3) and/or Requiring Redo-TAVR or Valve Explantation Time Frame: 5 years and 10 years post procedure	Number of participants experiencing significant structural valve deterioration (SVD) as defined by VARC-3 criteria. SVD will be assessed by transthoracic echocardiography (TTE) Number of participants requiring redo-TAVR or surgical valve explantation within 5 years and 10 years post-procedure.	5 years and 10 years post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceric Sàrl

Collaborators

European Cardiovascular Research Center

Investigators

Principal Investigator: Philippe Garot, European Cardiovascular Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Milojevic M, Myers PO, Falk V, Bavaria JE, Borger MA, Casselman FPA, Badhwar V, Kaul S, Siepe M, Sadaba JR. Methodological Appraisal of Ongoing Trial of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Younger Patients: From Incentives to Guideline-Informing Evidence. Eur J Cardiothorac Surg. 2025 Dec 1;67(12):ezaf348. doi: 10.1093/ejcts/ezaf348.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2037

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

START YOUNG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Symptomatic Severe Aortic Stenosis

Clinical Trials on Myval balloon-expandable THV Series

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