Treatment of severe calcified aortic stenosis in high risk patients.
Conditions
Interventions
Group 1: Evaluate the safety and effectiveness of the transfemoral NVT TAVI System in the treatment of severe calcified aortic stenosis in high risk patients.
Sponsors
NVT GmbH
Eligibility
Sex/Gender
All
Age
75 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient of both gender = 75 years old 2. Patient has severe degenerative aortic stenosis showing echocardiographically the following parameters: - Mean transvalvular pressure gradient > 40 mmHg and/or - Jet velocity > 4.0 m/s and/or - Initial aortic valve area of < 1.0 cm² (or aortic valve area index = 0.6 cm²/m²) Baseline measurement taken by echo within 45 days of enrolment. 3. Patient is considered at high risk for surgical aortic valve replacement with a logistic EuroSCORE = 20%, or documented agreement of the heart team that the patient is at high risk for surgery due to frailty and/or coexisting comorbidities. The following conditions presenting an elevated operative mortality risk of greater than 15% which is not captured by the risk score will be considered for inclusion into the trial: - Porcelain aorta or other preconditions which precludes cannulation for cardio-pulmonary bypass, cross-clamp application or surgical access to the mediastinum; - radiation treatment of the sternum that precludes an open chest procedure; - chest deformities or remote mediastinitis that preclude an open chest procedure; - other high-risk conditions e.g. prior thoracic or CABG surgery, chronic pulmonary dysfunction (FEV1 < 50). 4. Patient is symptomatic from aortic valve stenosis, as demonstrated by NYHA functional class II or greater. 5. Patient agrees to return to the study hospital for all required scheduled follow up visits. 6. Patient presents an aortic annulus diameter as measured by pre-procedural echocardiography or CT that corresponds to the available NVT Transcatheter Heart Valve size (19 mm = annulus = 29 mm). 7. Patient is capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and is able to form a rational intention in the light of these facts and has provided written informed consent for trial participation.
Exclusion criteria
Exclusion criteria: Anatomical exclusion criteria: 1. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified as detected by echo. 2. Mixed aortic valve disease with predominant aortic regurgitation greater than 3+. 3. Severe (greater than 3+) mitral insufficiency. 4. Distance between aortic valve basal plane and the orifice of the lowest coronary artery 3.0 mg/dl (264 µmol/l). 21. Active peptic ulcer or upper gastrointestinal bleeding within the past 90 days prior to index procedure. 22. History of bleeding diathesis or coagulopathy; acute blood dyscrasias as defined: leucopenia (WBC < 3,000), acute anemia (Hemoglobin < 10), thrombocytopenia (platelets < 80,000). 23. Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication (aspirin, heparin, or clopidogrel) or to Nitinol alloy or to bovine tissue. 24. Life expectancy less than 12 months due to non-cardiac co-morbid conditions based on the assessment of the investigator at the time of enrolment. 25. Currently participating in an investigational drug or another device study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| - Event rates peri- and postoperatively until 12 months follow-up - Device and procedural success - Prosthetic valve performance within one year and annually thereafter | — |
Countries
Brazil, Poland, Switzerland
Contacts
Public ContactMartin Faiss
NVT GmbH
Outcome results
None listed