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 groupsSponsors and collaborators
Xijing Hospital
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Fu Wai Hospital, Beijing, China
Collaborator
West China Hospital
Collaborator
Source ClinicalTrials.gov