NCT05989074

All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve

All Women A Multicenter Randomized Clinical Trial Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve in a Women Population

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Ceric Sàrl · Industry
• Sex: Female
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis

Detailed description

Study is aimed to demonstrate that the self-expandable Allegra transcatheter aortic valve implantation (TAVI) system provides lower mean gradient assessed by Transthoracic Echo (TTE) at 30 days post procedure, compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis. Patients in both arm will receive anticoagulants according to routine practice of the hospital. Patients will be followed-up until 1 year after the procedure.

Conditions

• Aortic Stenosis, Severe

Interventions

Type	Name	Description
DEVICE	ALLEGRA TAVI System TF	Patients receive ALLEGRA TAVI System TF. Patient will receive medication according to routine practice of the hospital
DEVICE	Ballon-expandable valve system	Patients receive any kind of CE-marked balloon expandable valve system, used at the hospital. Patient will receive medication according to routine practice of the hospital.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2023-08-14
• Last updated: 2024-01-12