Patients with severe aortic regurgitation
Conditions
Interventions
J-Valve Transcatheter Aortic Valve System treatment group:The J-Valve Transcatheter Aortic Valve System for the treatment of patients with severe aortic regurgitation
Sponsors
The Second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily participate, sign the informed consent form, and are able to cooperate in completing the entire research process; 2. Age >= 55 years; 3. Severe aortic regurgitation confirmed by echocardiography; 4. Study participants exhibit symptoms related to AR, with New York Heart Association (NYHA) functional class II or above; 5. The study participant is assessed by the heart team as requiring aortic valve replacement but unsuitable for conventional surgical treatment, while also being anatomically suitable for the J-Valve heart valve system.
Exclusion criteria
Exclusion criteria: 1. Congenital aortic valve malformations: unicuspid valve; 2. Previous implantation of an artificial aortic valve (bioprosthetic or mechanical); 3. Severe mitral or tricuspid valve disease requiring simultaneous surgical treatment; 4. Echocardiography reveals left-sided cardiac thrombus, intracardiac mass, or vegetation; 5. Presence of endocarditis or other active infections (not fully cured) within 180 days before the procedure; 6. Severe obstructive hypertrophic cardiomyopathy (transvalvular pressure gradient >70 mmHg); 7. Severe pulmonary hypertension (pulmonary artery systolic pressure >70 mmHg); 8. Severely reduced left ventricular ejection fraction (LVEF = 55 mm) and aortic dissection; 10. Any condition requiring emergency TAVR surgery; 11. Cardiogenic shock or hemodynamic instability within 30 days before the procedure, requiring inotropic support or ventricular assist device therapy; 12. Acute myocardial infarction within 30 days before the procedure; 13. Cerebrovascular events (including TIA, stroke) within 180 days before the procedure; 14. Severe renal insufficiency (GFR <30 mL/min) at screening or renal disease requiring renal replacement therapy within 180 days before the first TAVR procedure; 15. Active peptic ulcer or upper gastrointestinal bleeding within 90 days before the procedure; 16. Known allergies to heparin, aspirin, clopidogrel, contrast agents, nickel-titanium alloys, etc.; 17. Estimated life expectancy <12 months; 18. The study participant is enrolled in another ongoing clinical trial for other medical devices or drugs that requires follow-up for primary endpoints (Note: Participants in the long-term monitoring phase of another study are eligible to join this trial); 19. Severe dementia; 20. The study participant is unable to comply with the follow-up requirements of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 30 days postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success;Device success;Echocardiographic parameters;New York Heart Association (NYHA) functional class;All-cause mortality;All stroke;Life-threatening or major bleeding;Acute kidney injury (AKI) stage 2 or 3 (including renal replacement therapy);Major vascular complications;Valve-related reoperation/intervention;New permanent pacemaker implantation;Major adverse cardiac and cerebrovascular events (including death, myocardial infarction (MI), stroke, conduction block, malignant arrhythmia, and reoperation due to valve dysfunction); | — |
Countries
China
Contacts
Public ContactLi Yan
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed