Trials Sponsors Conditions Drugs Pricing

Conditions

Symptomatic Severe Aortic Stenosis

Outcome Measures

Primary Outcomes (3)

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.
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)
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.
1 month post procedure

Secondary Outcomes (23)

Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time
1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time
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
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
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
1, 2, 3, 4, 5, 7, 9, and 10 years
+18 more secondary outcomes

Study Arms (2)

TAVR: Myval balloon-expandable THV Series

EXPERIMENTAL

Myval balloon-expandable THV Series will be used for valve replacement

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

Device: Surgical bioprosthetic valve

Interventions

Myval balloon-expandable THV SeriesDevice

Patients receive Myval balloon-expandable THV Series (TAVR)

TAVR: Myval balloon-expandable THV Series

Surgical bioprosthetic valveDevice

Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)

SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site

Eligibility Criteria

Age65 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

Participant will be included if all the following criteria are met:
Patients aged ≥65 and ≤75

Sponsors & Collaborators

Ceric Sàrl
Industrylead
European Cardiovascular Research Center
Research networkcollaborator

Study Sites (49)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

Albrecht Schmidt, MDCONTACT+436641436694 albrecht.schmidt@medunigraz.at

Birgit Zirngast, MDCONTACT+436602144529 birgit.zirngast@medunigraz.at

University Hostpital Sankt Pölten

Sankt Pölten, 3100, Austria

RECRUITING

Related Publications (1)

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.
PMID: 41351226DERIVED

Study Officials

Philippe Garot
European Cardiovascular Research Center
PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Garot, MD

CONTACT

+330160134602 pgarot@angio-icps.com

Marie-Claude Morrice, MD

CONTACT

mcmorice@cerc-europe.org

Study Design

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

Study Record Dates

First Submitted

February 19, 2025

First Posted

March 6, 2025

Study Start

May 15, 2025

Actual (reported)

Primary Completion

September 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (23)

Study Arms (2)

TAVR: Myval balloon-expandable THV Series

SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (49)

Related Publications (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (23)

Study Arms (2)

TAVR: Myval balloon-expandable THV Series

SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (49)

Related Publications (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations