NCT06861361

Surgical vs Transcatheter Aortic Valve Replacement in Young Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,180 (estimated)
• Sponsor: Ceric Sàrl · Industry
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Myval balloon-expandable THV Series	Patients receive Myval balloon-expandable THV Series (TAVR)
DEVICE	Surgical bioprosthetic valve	Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)

Timeline

• Start date: 2025-05-15
• Primary completion: 2027-11-01
• Completion: 2031-11-01
• First posted: 2025-03-06
• Last updated: 2025-12-18

Locations

7 sites across 3 countries: France, Spain, Switzerland