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

Launched by JENAVALVE TECHNOLOGY, INC. · Sep 7, 2022

Keywords

ClinConnect Summary

The TAVIS Registry is a clinical trial designed to gather information about how well the Trilogy Heart Valve System works for patients with severe aortic valve disease, which includes conditions like aortic stenosis (narrowing of the aortic valve) and aortic regurgitation (leaking of the aortic valve). This trial is particularly focused on helping patients who have symptoms from these conditions and are at a high risk for traditional surgery. It is not yet recruiting participants, but it aims to include adults 18 years and older who meet specific criteria set by their doctors.

Eligible participants will be individuals who have been diagnosed with severe symptoms from their aortic valve disease and are willing to undergo a new treatment using the Trilogy Heart Valve System. They must agree to follow-up visits after the procedure to monitor their health. However, certain patients, such as those with specific allergies, active infections, or previous heart valve surgeries, will not be able to participate. If you or someone you know has severe aortic valve disease and is interested in this trial, it’s important to discuss it with a healthcare provider to see if this new treatment might be a good fit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. 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
• • 3. Patients 18 years of age or older
• • 4. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the study
• • 5. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
• Exclusion Criteria:
• • 1. 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
• • 2. Patients who have active bacterial endocarditis or other active infections
• • 3. Pediatric (\<18 years) and/or pregnant/nursing patients
• • 4. Congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology
• • 5. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
• • 6. Echocardiographic evidence of current left heart thrombus
• • 7. Hypertrophic cardiomyopathy with or without obstruction.
• • 8. 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.