Aortic Stenosis, Severe, Aortic Valve Disease, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Cardiovascular Diseases in Old Age, Constriction, Pathologic, Heart Valve Diseases, Ventricular Outflow Obstruction
Conditions
Keywords
Trilogy, Aortic Valve Disease, Transcatheter aortic valve replacement (TAVR), Aortic Valve Regurgitation
Brief summary
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
Detailed description
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.
Interventions
TAVI with the JenaValve Trilogy Heart Valve System
Sponsors
JenaValve Technology, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30-days post-index procedure | Mortality from any cause in patients receiving TAVI for AR or AS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 1 year | Reported death in patients participating in TAVIS Registry |
| Stroke | 30 days and 1 year | Reported stroke in patients participating in TAVIS Registry |
| Major vascular complications | 30 days | Reported vascular complications in patients participating in TAVIS Registry |
| Major and life-threatening bleeding | 30 days | Reported major and life-threatening bleeding complications in patients participating in TAVIS Registry |
| New conduction defects requiring permanent pacemaker | 30 days | Reported conduction defects requiring permanent pacemaker in patients participating in TAVIS Registry |
| Acute kidney injury stage 2-3 | 7 days | Reported kidney injury complications in patients participating in TAVIS Registry |
| New onset atrial fibrillation | 30 days | Reported new onset atrial fibrillation in patients participating in TAVIS Registry |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORStephan Baldus, MD
University Hospital of Cologne Heart Center
PRINCIPAL_INVESTIGATORHendrik Treede, MD
Johannes Gutenberg University Mainz
Outcome results
None listed