Surgical Vs Transcatheter Aortic Valve Replacement in Young Patients

Launched by CERIC SÀRL · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two types of heart surgeries for patients aged 65 to 75 who have a serious heart condition called symptomatic severe aortic stenosis. This condition means that the aortic valve in the heart is narrowed and makes it hard for blood to flow, causing symptoms like chest pain or trouble breathing. The study aims to see if a new type of valve replacement called Myval, which is inserted using a catheter, works just as well as the traditional surgery called surgical aortic valve replacement (SAVR).

To be eligible for this trial, participants must be between 65 and 75 years old and diagnosed with symptomatic severe aortic stenosis. They should be approved for either the new valve procedure or the traditional surgery by a team of heart specialists. Participants in the trial will be closely monitored, and they will need to give their consent to take part. Importantly, those with a life expectancy of less than a year or certain allergies may not be able to join. This trial is not yet recruiting participants, but it aims to improve treatment options for older adults with this heart condition.

Gender

ALL

Eligibility 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