An interventional study of Transcatheter aortic valve replacement in Diseases of Aortic Valve and Aortic Stenosis Disease, sponsored by Genesis Medtech Corporation. Completed at 15 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Genesis Medtech Corporation · Not applicable, Interventional, and Treatment
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.
This study is a prospective, multicenter, single-arm, clinical study.
231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.
This study's enrollment of 15 is below the median of 108 across 116 interventional studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Genesis Medtech Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: J-Valve® valve delivery system， Transvascularized biological aortic valve system
Device: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement system
Cumulative all-cause mortality
All-cause mortality within 12 months of TAVR procedure
Time frame: 12 months
Device success
No operative death;The instrument was placed in the correct anatomical position, and the delivery assembly was successfully entered and withdrawn;No device-related surgical or interventional intervention (other than permanent pacemaker implantation)
Time frame: 30 days
Procedural success
Technical success,No death,No device-related surgical or interventional intervention (except permanent pacemaker implantation),The artificial aortic valve achieved the expected value (mean transaortic pressure difference \< 20mmHg or transaortic flow velocity \< 3m/s; No moderate or greater artificial aortic regurgitation or perivalvular leakage)
Time frame: : immediate post-surgical
Evaluation of bioprosthetic valve and cardiac function Evaluation of bioprosthetic valve and cardiac function Evaluation of bioprosthetic valve and cardiac function
Echocardiography was used to evaluate aortic valve function and cardiac function
Time frame: 30 days, 6 months, 12 months
Functional Improvement of heart ( NYHA）
NYHA classification of cardiac function was evaluated after operation
Time frame: 30 days, 6 months, 12 months
Quality of life（KCCQ）
Evaluation of postoperative Quality of life score improvement (KCCQ)
Time frame: 30 days, 6 months, 12 months
Major cardiovascular and cerebrovascular adverse events (MACCE)
Major adverse cardiovascular and cerebrovascular events (MACCE) included mortality, stroke, myocardial infarction, reoperation, arrhythmia, and conduction block.
Time frame: before discharge/7days, 30 days, 6 months, 12 months
Myocardial infarction
Incidence of myocardial infarction
Time frame: before discharge/7days, 30 days, 6 months, 12 months
Stroke
Grades include ischemic stroke (including transient ischemic attack, TIA) and hemorrhagic stroke Grades included ischemic stroke (including transient ischemic attack, TIA) and hemorrhagic stroke; Definitions included disabling stroke (modified Rankin score ≥2 at 90 days after stroke with an increase of \>1 point) and nondisabling stroke (modified Rankin score \<2 at 90 days after stroke with no increase in score). Stroke events should be recorded and the causes analyzed in detail.
Time frame: before discharge/7days, 30 days, 6 months, 12 months
Major bleeding (life-threatening or crippling)
Severe bleeding: BARC bleeding was defined as type 3a and above
Time frame: before discharge/7days, 30 days, 6 months, 12 months
Acute kidney injury
The incidence of AKIN stage 2 and above events was recorded.
Time frame: before discharge/7days, 30 days, 6 months, 12 months
Conduction block and malignant arrhythmia
The incidence of conduction block and malignant arrhythmias
Time frame: before discharge/7days, 30 days, 6 months, 12 months
Permanent pacemaker implantation
Permanent pacemaker implantation rate
Time frame: before discharge/7days, 30 days, 6 months, 12 months
TAVI related complications
These include conversion to surgery, accidental mechanical cardiopulmonary assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, cardiac tamponade, endocarditis, valve thrombosis, valve ectopic (displacement, embolization, misrelease), aortic dissection, aortic root rupture, and peripheral vascular complications.
Time frame: before discharge/7days, 30 days, 6 months, 12 months
Device defects
Incidence of device defects
Time frame: intraoperative
The incidence of adverse events The incidence of adverse events
Incidence of adverse events
Time frame: 12 months
The incidence of serious adverse events
Incidence of serious adverse events
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Genesis Medtech Corporation