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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 70
Healthy Volunteers: f
View:

⁃ Subjects must meet ALL of the following inclusion criteria to be eligible for participation:

• 50 years of age or older but ≤70 years old at time of consent.

• Severe AS, defined as follows:

• a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \<50%.

• Tricuspid aortic valve stenosis and type-1 bicuspid aortic valve anatomy confirmed by MDCT.

• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

• Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant.

• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

Locations
Other Locations
China
Fuwai Hospital, Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
Shanghai Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
RECRUITING
Xi'an
Contact Information
Primary
Jian Yang, MD, PhD
yangjian@fmmu.edu.cn
+8613892828016
Backup
Meng en Zhai, PhD
zhaimengen@126.com
+8617782801836
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2031-06-30
Participants
Target number of participants: 450
Treatments
300 retrospectively enrolled patients
Procedure: TAVR
150 prospectively enrolled patients
Procedure: TAVR
Sponsors
Collaborators: West China Hospital, Fu Wai Hospital, Beijing, China, Shanghai Zhongshan Hospital
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov