TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJenaValve Technology, Inc.

About this trial

To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transcatheter Aortic Valve Implantation (TAVI)

Treatment groups

600 Participants
are divided into 1 treatment group

Sponsors and collaborators