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

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

Detailed Description
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Aortic stenosis (AS) is a narrowing of the aortic valve opening causing restricted blood flow from the left ventricle to the aorta and may also affect the pressure in the left atrium. Aortic regurgitation (AR) is a condition where the aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of AS and AR may include fatigue and shortness of breath. Aortic valve disease can affect both elderly and younger populations. TAVIS Registry will collect data from patients suffering from either AS or AR using a minimally invasive transcatheter aortic valve implantation procedure.

Official Title
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Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study

Conditions
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Aortic Valve Stenosis, Aortic Valve Regurgitation, Aortic Valve Stenosis With Insufficiency, Constriction, Pathologic, Aortic Valve Disease, Heart Valve Diseases, Cardiovascular Diseases in Old Age, Ventricular Outflow Obstruction, Aortic Stenosis, Severe

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation (TAVI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Previous prosthetic aortic valve (bioprosthesis or mechanical) implant Echocardiographic evidence of current left heart thrombus 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trilogy TAVI<br>Patients receiving JenaValve Trilogy Heart Valve System for management of symptomatic, severe aortic stenosis (AS)/ aortic regurgitation (AR) who are at high risk for surgical aortic valve replacement (SAVR) | Device: Transcatheter Aortic Valve Implantation (TAVI)<br>* TAVI with the JenaValve Trilogy Heart Valve System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Mortality from any cause in patients receiving TAVI for AR or AS | 30-days post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Reported death in patients participating in TAVIS Registry | 1 year | 
| Stroke | Reported stroke in patients participating in TAVIS Registry | 30 days and 1 year | 
| Major vascular complications | Reported vascular complications in patients participating in TAVIS Registry | 30 days | 
| Major and life-threatening bleeding | Reported major and life-threatening bleeding complications in patients participating in TAVIS Registry | 30 days | 
| New conduction defects requiring permanent pacemaker | Reported conduction defects requiring permanent pacemaker in patients participating in TAVIS Registry | 30 days | 
| Acute kidney injury stage 2-3 | Reported kidney injury complications in patients participating in TAVIS Registry | 7 days | 
| New onset atrial fibrillation | Reported new onset atrial fibrillation in patients participating in TAVIS Registry | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trilogy, Aortic Valve Disease, Transcatheter aortic valve replacement (TAVR), Aortic Valve Regurgitation