NCT06830499

Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China

Safety, Effectiveness and Durability of Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study

Detailed description

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with severe aortic stenosis (AS). Currently TAVR indication has expanded to intermediate and low-risk patients from inoperable or high-risk patients, through a rigorous series of clinical trials comparing TAVR with surgical aortic valve replacement (SAVR). Despite 2020 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommended SAVR for patients with symptomatic severe AS aged \<65 years, the previous data from United States nationwide Vizient Clinical Data Base and Northern New England Cardiovascular Disease Group Consortium (NNECDSG) registry demonstrated dramatic growth in TAVR utilization in younger patients aged \<65 years from 2015 to 2021/2022, which is possibly driven by increased TAVR utilization in low surgical risk patients. However, TAVR has never been systematically tested in young (\<65 years old), low-risk patients, with many unanswered questions, especially the safety and effectiveness of TAVR in patients with bicuspid aortic valves and the durability of transcatheter heart valves. Furthermore, we noticed that the patients between 65 years old and 70 years old accounted for 23.3% of all the TAVR patients and this patient subgroup were underrepresented in the previous study, which makes it necessary to also explore the interested endpoints in this subgroup. The aim of this study is to establish the safety and efficacy of Sapien 3 TAVR in young (50\~70 years old) Chinese patients with severe symptomatic AS, including Type-1 bicuspid population and to explore the durability performance of Sapien 3 in this cohort.

Conditions

• AORTIC VALVE DISEASES
• Bicuspid Aortic Valve (BAV)

Interventions

Type	Name	Description
PROCEDURE	Transcatheter Aortic Valve Replacement (TAVR)	TAVR procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted. Vascular access site will be through transfemoral on the basis of pre-procedural evaluation of access site vessel. The procedure will be performed under local or general anesthesia and per clinical practice standard.

Timeline

• Start date: 2025-04-24
• Primary completion: 2031-06-30
• Completion: 2031-06-30
• First posted: 2025-02-17
• Last updated: 2025-06-19

Locations

4 sites across 1 country: China