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
This trial does not accept healthy volunteersQualifiers
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 population
Young (50\~70 years old) Chinese patients with severe symptomatic AS, including Type-1 bicuspid population
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Transcatheter Aortic Valve Replacement (TAVR)
Procedure/SurgeryTAVR 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.
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: 300 retrospectively enrolled patients1 intervention
Group B: 150 prospectively enrolled patients1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality
The primary end point is the 5 year all-cause mortality
Time frame
At 5 yearsSecondary outcomes
1
The composite of all-cause mortality, stroke and rehospitalization
The composite of all-cause mortality, stroke, rehospitalization (procedure, valve and heart failure related) at 30 days, 1, 3, 5 years
Time frame
At 30 days, 1, 3, 5 years2
The composite of device success
The composite of device success at 30 days comprising the following: freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication, intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation), according to the VARC-3 definition
Time frame
At 30 days3
The durability performance of Sapien 3
The durability performance of Sapien 3 at 1, 3, 5 years: bioprosthetic valve dysfunction (BVD, including SVD, non-SVD, endocarditis and thrombosis), moderate or severe hemodynamic valve deterioration (HVD), bioprosthetic valve failure (BVF) according to the VARC-3 definition, EOA/mean gradient (MG) change over follow up
Time frame
At 1, 3, 5 years4
Annular rupture
The incidence of annular rupture
Time frame
At 1 day of dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xijing Hospital
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Fu Wai Hospital, Beijing, China
Collaborator
West China Hospital
Collaborator
Source ClinicalTrials.gov