Symptomatic Severe Aortic StenosisSTART YOUNGNCT06861361
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
A study testing Myval balloon-expandable THV Series and Surgical bioprosthetic valve in people with Symptomatic Severe Aortic Stenosis, run by Ceric Sàrl at 49 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Symptomatic Severe Aortic Stenosis
- What is being tested?
- Myval balloon-expandable THV Series and Surgical bioprosthetic valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,180 participants
- Where
- 49 sitesin 14 countries
- Study dates
- 15 May 2025to Sep 2037
- Phase
- Interventional
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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
49 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
Marie-Claude Morrice, MD contact
49 sites in 14 countries
United Kingdom10 sites, 10 recruiting
- Not yet recruiting
Royal Victoria Hospital
Belfast
Colum Owens, MD, +447749475293, Colum.owens@belfasttrust.hscni.net
Reuben Jeganathan, MD, +44077762354590, Reuben.jeganathan@belfastrust.hscni.net
- Recruiting
University Hospital Sussex NHS foundation Trust
Brighton
David Hildick-Smith, MD, +441273696955/I64049, david.hildick-smith@nhs.net
Uday Trivedi, MD, +441273696955/64049, uday.trivedi@nhs.net
- Not yet recruiting
Royal Papworth Hospital
Cambridge
Charis Costopoulos, MD, charis.costopoulos@nhs.net
John Taghavi, MD
- Recruiting
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Cottingham
Raj Chelliah, MD, +447748101796, g.mikhail@imperial.ac.uk
Emad Aljaaly, MD, +447748101796, dumbor.ngaage@nhs.net
- Recruiting
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
Nishant Gangil, MD, +447469 316628, nishant.gangil@uhcw.nhs.uk
Tom Barker, MD, +447469 316628, Tom.Barker@uhcw.nhs.uk
- Recruiting
Barts Heart Centre
London
Mick Ozkor, MD, +447590202577, mick.ozkor@nhs.net
Andreas Baumbach, MD, baumbach.andreas@nhs.net
- Recruiting
Imperial College Healthcare NHS Trust
London
Ghada Mikhail, MD, +447778809331, g.mikhail@imperial.ac.uk
Emad Aljaaly, MD, emad.aljaaly@nhs.net
- Not yet recruiting
Freeman Hospital
Newcastle upon Tyne
Mohamed Farag, MD, +441912139920, mohamedfarag@nhs.net
Faruk Oezalp, MD, +441912336161, faruk.oezalp1@nhs.net
- Not yet recruiting
Sheffield Teaching Hopitals NHS Foundation Trust
Sheffield
Javaid Iqbal, MD, +447788438471, javaid.iqbal3@nhs.net
Norman Briffa, MD, +441142714951, n.briffa@nhs.net
- Recruiting
Morriston Hospital
Swansea
Ayush Khurana, MD, +447709363270, Colum.owens@belfasttrust.hscni.net
Fabio Falconieri, MD, +447709363270, fabio.falconieri@wales.nhs.uk
Poland7 sites, 7 recruiting
- Not yet recruiting
Poznan University Hospital
Poznan, 61848
Marek Grygier, MD, +48501066432, mgrygier@wp.pl
Marek Jemielity, MD, +48618549210, mjemielity@poczta.onet.pl
- Not yet recruiting
Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, 70111
Jaroslaw Goracy, MD, +48600801616, jargo62@gmail.com
Piotr Pacholewicz, MD
- Not yet recruiting
Medical Univeristy of Warsaw
Warsaw, 02097
Janusz Kochman, MD, +48605051172, jkochman@wum.edu.pl
Radosław Wilimski, MD, +48609510678, radoslaw.wilimski@wum.edu.pl
- Not yet recruiting
National Institute of Cardiology
Warsaw, 04628
Adam Witkowski, MD, +48223434127, witkowski@hbz.pl
Piotr Kołsut, MD, +48223434610, pkolsut@ikard.pl
- Not yet recruiting
Military Institute of Medicine in Warsaw
Warsaw
Piotr Kwiatkowski, MD, +48606619195, pkwiatkowski@wim.mil.pl
Michal Zebala, MD, +48600402994, kardiochirurgia@wim.mil.pl
- Not yet recruiting
Military Hospital in Wroclaw
Wroclaw, 50981
Ściborski Krzysztof, MD, k.sciborski@4wsk.pl
Marek Mak, MD, +48608367407, aureliuszm@tlen.pl
- Not yet recruiting
Provincial Specialist Hospital in Wroclaw
Wroclaw
Marcin Protasiewicz, MD, mprot@poczta.onet.pl
Romuald Cichoń, MD, romuald.cichon@gmx.de
Italy6 sites, 6 recruiting
- Not yet recruiting
Montevergine Clinic
Mercogliano, 83013
Luigi Salemme, MD, +393493114639, lsalemme63@gmail.com
Carlo Zebele, MD, +393392919314, carlo.zebele@gmail.com
- Not yet recruiting
IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, 20157
Alfonso IELASI, MD, +39 338 843 3189, alfonso.ielasi@gmail.com
Mattia Glauber, MD, +39 348 393 1043, mattia.glauber@gmail.com
- Not yet recruiting
Centro Cardiologico Monzino IRCCS
Milan
Federico De Marco, MD, +393286242014, federico.demarco@gmail.com
Gianluca Polvani
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126
Davide Capodanno, MD, dcapodanno@gmail.com
Salvatore Lentini, MD, eiko251961@gmail.com
- Not yet recruiting
Fondazione Policlinico Campus Bio-Medico di Roma
Roma, 00128
Gian Paolo Ussia, MD, g.ussia@policlinicocampus.it
Raffaele Barbato, MD, m.chello@policlinicocampus.it
- Not yet recruiting
IRCCS Policlinico San Donato
San Donato Milanese, 20097
Luca Testa, MD, +393490808660, luctes@gmail.com
Carlo De Vincentiis, MD, +390252774980, sgrcardiologiaclinica.PSD@grupposandonato.it
France5 sites, 5 recruiting
- Recruiting
CHU Lille
Lille
Van Belle, +33 3 20 44 53 01, eric.vanbelle@chu-lille.fr
- Recruiting
Infirmerie Protestante de Lyon
Lyon
Esteve, +33 6 48 15 82 67, dr.esteve@infirmerie-protestante.com
- Recruiting
Massy-Hôpital Jacques Cartier
Massy
Garot, + 33 1 60 13 46 02, pgarot@angio-icps.com
- Not yet recruiting
CHU de Rouen
Rouen
Eltchaninoff, + 33 2 32 88 82 32, helene.eltchaninoff@chu-rouen.fr
- Recruiting
Clinique Pasteur
Toulouse
Tchetche, +33562211699, d.tchetche@clinique-pasteur.com
Germany4 sites, 4 recruiting
- Not yet recruiting
University Hospital Frankfurt
Frankfurt, 60596
Philipp C. Seppelt, MD, +4969630180397, Philipp.Seppelt@herz-frankfurt.de
Thomas Walther, MD, +496963016141, Thomas.Walther@herz-frankfurt.de
- Not yet recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Nils Sörensen, MD, +4915222815518, n.soerensen@uke.de
Andreas Schäfer, MD, and.schaefer@uke.de
- Not yet recruiting
German Heart Munich
München, 80636
Magdalena Erlebach, MD, erlebach@dhm.mhn.de
Felix Wirth, +498912182973, wirth@dhm.mhn.de
- Not yet recruiting
Krankenhaus der Barmherzigen Brüder Trier
Trier, 54292
Nikos Werner, MD, +496512082784, n.werner@bbtgruppe.de
Assad Haneya, MD, +496512082751, a.haneya@bbtgruppe.de
Austria3 sites, 3 recruiting
- Recruiting
Medical University of Graz
Graz, 8036
Albrecht Schmidt, MD, +436641436694, albrecht.schmidt@medunigraz.at
Birgit Zirngast, MD, +436602144529, birgit.zirngast@medunigraz.at
- Recruiting
University Hostpital Sankt Pölten
Sankt Pölten, 3100
Julia Mascherbauer, MD, +436644272024, julia.mascherbauer@stpoelten.lknoe.at
Dominik Wiedemann, MD, +432742900421400, Dominik.wiedemann@stpoelten.lknoe.at
- Recruiting
Medical University of Vienna
Vienna, 1090
Philipp E Bartko, MD, +4314040048590, philippemanuel.bartko@meduniwien.ac.at
Iuliana Coti, MD, +4314040047031, iuliana.coti@meduniwien.ac.at
Hungary3 sites, 3 recruiting
- Not yet recruiting
Gottsegen National Cardiovascular Center
Budapest
Peter Andreka, MD, +36703820270, peter.andreka@gokvi.hu
Jeno Szolnoky, MD, +36303991528, jeno.szolnoky@gokvi.hu
- Not yet recruiting
Department of Cardiology and Cardiac Surgery, University of Debrecen
Debrecen
Attila Béla Kertész, MD, +36303996248, kertesz@med.unideb.hu
Tamás Szerafin, MD, +36303905003, szerafin@hotmail.com
- Not yet recruiting
University of Szeged
Szeged
Zoltán Ruzsa, MD, +36203338490, zruzsa25@gmail.com
Gábor Bari, MD, +36203338490, drbarigabor@gmail.com
Romania3 sites, 3 recruiting
- Not yet recruiting
Bucharest Clinical Emergency Hospital
Bucharest
Lucian Calmac, MD, +40722742943, lcalmac@gmail.com
Horațiu Moldovan, MD, +40729963785, h_moldovan@hotmail.com
- Not yet recruiting
Central military emergency university hospital
Bucharest
Mohamed Khattab, MD, +40720641142, moeran2003@yahoo.com
Liviu Stan, MD, +40722320252, liviustan@gmail.com
- Not yet recruiting
IBCV Iasi
Iași
Igor Nedelciuc, MD, +40722742943, inedel@yahoo.com
Grigore Tinica, MD, +40729963785, grigoretinica@yahoo.com
Serbia2 sites, 2 recruiting
- Not yet recruiting
University Clinical Center of Serbia
Belgrade
Zlatko Mehmedbegovic, MD, +381606678761, zlatkombegovic@gmail.com
Svetozar Putnik, MD, +381637234560, svetozar073@yahoo.com
- Recruiting
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz
Mila Kovačević, MD, +381601594444, milakov979@gmail.com
Lazar Velicki, MD, +38163723456, lvelicki@gmail.com
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Pablo Avanzas, MD, +34696476274, avanzas@secardiologia.es
Esther Villa, +34616112327, fundacionasturcor@gmail.com
- Recruiting
Hospital clínico universitario de Valladolid
Valladolid
Ignacio Amat Santos, MD, +34 983420026, ijamat@gmail.com
Estonia1 site, 1 recruiting
- Recruiting
North-Estonia Medical Centre Foundation
Tallinn, 13419
Peep Laanmets, MD, +37256616187, peep.laanmets@regionaalhaigla.ee
Gynter Taal, MD, +37256608409, Gynter.taal@regionaalhaigla.ee
Portugal1 site, 1 recruiting
- Recruiting
Hospital de Santa Cruz, ULSLO
Carnaxide
Rui Campante Teles, MD, +351936097171, rcteles@outlook.com
Tiago Nolasco, MD, +351917831100, tiagodnolasco@gmail.com
Slovenia1 site, 1 recruiting
- Recruiting
UKC Ljubljana
Ljubljana, 1000
Matjaz Bunc, MD, +38641757473, mbuncek@yahoo.com
Tadeja Kolar, MD, tkolar17@gmail.com
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne
David Meier, MD, +41 79 556 38 33, david.meier@chuv.ch
Matthias Kirsch, +41 79 556 52 43, matthias.kirsch@chuv.ch
About this study
Official title: 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.
Read the 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).
- Conditions
- Symptomatic Severe Aortic Stenosis
- Being tested
- Myval balloon-expandable THV Series, Surgical bioprosthetic valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myval balloon-expandable THV SeriesDevice
Patients receive Myval balloon-expandable THV Series (TAVR)
Surgical bioprosthetic valveDevice
Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)
| Study group | Role | What they receive |
|---|---|---|
| TAVR: Myval balloon-expandable THV Series | Experimental | Myval balloon-expandable THV Series will be used for valve replacement Receives: Device: Myval balloon-expandable THV Series |
| SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site | Active comparator | Surgical bioprosthetic valve commercially available at the clinical investigation site will be used for valve replacement Receives: Device: Surgical bioprosthetic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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
Composite measure of all-cause death, any stroke, or rehospitalization for valve related event at 1 year (VARC-3 definition)
Measured: 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).
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.
Measured: 1 month post procedure
Secondary outcomes (23)
Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time
Number of participants who experience all-cause mortality at each follow-up time point.
Measured: 1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time
Number of participants with any stroke (ischemic or hemorrhagic) as defined by clinical assessment and imaging confirmation.
Measured: 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
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
Measured: 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
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
- 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
- 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
Measured: 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
Number of participants requiring rehospitalization due to procedure-related complications.
Measured: 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
Number of participants requiring reintervention (redo-TAVR, SAVR, or valve explantation) due to aortic valve dysfunction.
Measured: 1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Feasibility of re-TAVR based on CT scan evaluation (CT scan, for selected sites only)
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.
Measured: 1 month post procedure
Secondary Endpoint: Number of Participants Requiring New Permanent Pacemaker Implantation (PPI) Due to Conduction System Disturbances
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.
Measured: 1 month post procedure
Secondary Endpoint: Rate of prosthetic valve regurgitation (moderate or severe)
Measured: 1 year post procedure
Secondary Endpoint: Number of Participants with Major Vascular Complications (VARC-3 Criteria)
Number of participants experiencing major vascular complications within 1 month post-procedure, as defined by VARC-3 criteria.
- 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
Measured: 1 month post procedure
Secondary Endpoint: Performance of the aortic valve : Gradients (mean/max) assessed by TTE
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).
Measured: 1 year and 3 years post procedure
Secondary Endpoint: Performance of the aortic valve : paravalvular leakage (PVL) grade evaluated by transthoracic echocardiogram (TTE)
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.
Measured: 1 year and 3 years post procedure
Secondary Endpoint: Performance of the aortic valve : effective orifice are (EOA) evaluated by transthoracic echocardiogram (TTE)
Effective orifice area (EOA) (cm²) measured using the continuity equation on TTE.
Values will be reported as mean ± standard deviation (SD).
Measured: 1 year and 3 years post procedure
Secondary Endpoint: Number of Participants with Structural Valve Deterioration (VARC-3) and/or Requiring Redo-TAVR or Valve Explantation
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.
Measured: 5 years and 10 years post procedure
CT Scan Sub Study endpoints: Secondary outcomes : feasibility of redoTAVR or ViV TAVR with or without requiring leaflet modification techniques
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.
Measured: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: prevalence of HALT in both TAVR and SAVR groups
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.
Measured: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Mean Transvalvular Gradient - Valve Hemodynamics
- 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.
Measured: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Peak Transvalvular Gradient - Valve Hemodynamics
- 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.
Measured: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Effective Orifice Area (EOA) - Valve Hemodynamics
- 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.
Measured: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Mean Transvalvular Gradient - THV Hemodynamics
- 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.
Measured: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Peak Transvalvular Gradient - THV Hemodynamics
- 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.
Measured: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Effective Orifice Area (EOA) - THV Hemodynamics
- Outcome Measure: Effective orifice area (cm²) measured by TTE post-implantation.
- Time Frame: 1 month post-procedure
- Unit of Measure: cm²
Measured: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Commissural Alignment of THV
Mean commissural misalignment angle (degrees) measured by CT scan to evaluate THV positioning relative to native aortic valve commissures.
Measured: 1 month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start15 May 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2037 (estimated)
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 Symptomatic Severe Aortic StenosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Philippe Garot, Principal investigator, European Cardiovascular Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861361
- Sponsor's protocol ID
- START YOUNG
- Acronym
- START YOUNG
- Status last verified
- May 2026
- First submitted
- 19 Feb 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 41351226