To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
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
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
Patients who have active bacterial endocarditis or other active infections
Pediatric (<18 years) and/or pregnant/nursing patients
Congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology
Patients with symptomatic severe aortic regurgitation or symptomatic severe aortic stenosis undergoing treatment with JenaValve Trilogy Heart Valve System
Case-control
Other
Transcatheter Aortic Valve Implantation (TAVI)
DeviceTAVI with the JenaValve Trilogy Heart Valve System
All-cause mortality
Mortality from any cause in patients receiving TAVI for AR or AS
Death
Reported death in patients participating in TAVIS Registry
Stroke
Reported stroke in patients participating in TAVIS Registry
Major vascular complications
Reported vascular complications in patients participating in TAVIS Registry
Major and life-threatening bleeding
Reported major and life-threatening bleeding complications in patients participating in TAVIS Registry
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This trial is not recruiting at the moment. You can still explore other options:
