Home › Trials › NCT06861361

Surgical versus transcatheter aortic valve replacement for patients aged 65–75

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

Not applicable Interventional Ceric Sàrl · NCT06861361

This trial will test whether the Myval transcatheter heart valve works as well as surgical bioprosthetic aortic valve replacement for people aged 65 to 75 with symptomatic severe aortic stenosis.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1180 (estimated)
Ages65 Years to 75 Years
SexAll
SponsorCeric Sàrl Industry-sponsored
Locations49 sites (Graz and 48 other locations)
Trial IDNCT06861361 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, open-label, multinational trial that will enroll 1,180 patients with symptomatic severe native calcific aortic stenosis aged 65–75. Participants are randomized to receive either a Myval balloon-expandable transcatheter heart valve (transfemoral TAVR) or a surgical bioprosthetic aortic valve replacement (SAVR). The primary objective is to demonstrate non-inferiority of clinical outcomes with the Myval series compared with SAVR as judged by predefined endpoints determined by a multidisciplinary heart team. The trial is being conducted across multiple centers with standard follow-up to compare safety and efficacy between the two approaches.

Who should consider this trial

Good fit: Ideal candidates are people aged 65–75 with symptomatic severe native calcific aortic stenosis for whom both transfemoral TAVR and surgical valve replacement are considered feasible by a multidisciplinary heart team.

Not a fit: Patients unlikely to benefit include those with life expectancy under one year, known hypersensitivity to aspirin, clopidogrel, or device frame components, inability to follow the protocol, or those judged unsuitable for transfemoral access or surgery by the heart team.

Why it matters

Potential benefit: If successful, the transcatheter Myval approach could offer outcomes similar to surgery while providing a less invasive option with potentially faster recovery.

How similar studies have performed: Previous large randomized trials have shown TAVR to be non-inferior or superior to surgery in older and intermediate-risk populations, but randomized evidence specifically focused on the 65–75 age group is more limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

1. Patients aged ≥65 and ≤75
2. Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\>4m/sec).
3. 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:

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

Where this trial is running

Graz and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Symptomatic Severe Aortic Stenosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.