TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
Megadott ok: Inadequate study design which restricted study enrollment suitable for a registry.
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A vizsgálat adatai
- Ki végzi
- JenaValve Technology, Inc.
- Azonosító
- NCT05536310
- A regiszteradat frissítve
- 2026. augusztus 21.
- Eredeti leírás
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).A teljes eredeti leírásKevesebb
Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
Bevonási feltételek: Patients who have signed ICF and are indicated by their doctors to be treated with Trilogy Heart Valve System in line with the medical standard of care; Patients with symptomatic severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are at high risk for SAVR as documented by the heart team and Heart Team agrees that patient can undergo SAVR for "bail out"/to address unfavorable circumstances if necessary; Patients 18 years of age or older; Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the study; The subject and treating physician agree the subject will return for all required post-procedure follow-up visits.
Kizáró feltételek: Previous prosthetic aortic valve (bioprosthesis or mechanical) implant; Patients who have active bacterial endocarditis or other active infections; Echocardiographic evidence of current left heart thrombus; Patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication; Pediatric (<18 years) and/or pregnant/nursing patients; Congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology; Hypertrophic cardiomyopathy with or without obstruction; Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter <7mm.