Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-70
SponsorXijing Hospital
About this trial
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 criteria
Qualifiers
50 years of age or older but ≤70 years old at time of consent.
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.
Disqualifiers
Any of the following: a. no calcification; b. challenging calcification based on physician's experience and discretion (Case Review Board would decide whether to exclude challenging calcification cases).
Aortic valve is a congenital unicuspid valve, congenital Type-0 or Type-2 bicuspid valve, or quadricuspid valve.
Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR.
Evidence of an acute myocardial infarction ≤ 1 month (30 days), with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.
Trial design
Treatments tested in this trial
- Transcatheter Aortic Valve Replacement (TAVR)
Treatment groups
450 Participants
are divided into 2 treatment groupsLocations
4Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University710032, Xi'anShaanxi, China
West China Hospital, Sichuan University ChengduSichuan, China
Fuwai Hospital, Chinese Academy of Medical Sciences Beijing China
Shanghai Zhongshan Hospital, Fudan University Shanghai China
Sponsors and collaborators
Xijing Hospital
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Fu Wai Hospital, Beijing, China
Collaborator
West China Hospital
Collaborator
Source ClinicalTrials.gov