Prospective, multi-centric, single arm pivotal trial to evaluate the safety and effectiveness of the transfemoral NVT TAVI System in the treatment of severe calcified aortic stenosis in high risk patients.
- Conditions
- Treatment of severe calcified aortic stenosis in high risk patients.
- Registration Number
- DRKS00006042
- Lead Sponsor
- VT GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 74
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.
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 < 8 mm.
5.Pre-existing prosthetic heart valve or prosthetic ring in any position.
6.Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
7.Hypertrophic obstructive cardiomyopathy.
8.Significant aortic disease such as severe obstructive calcification or marked tortuosity which will preclude a safe advancement of the NVT TAVI System.
9.Femoral artery lumen diameter < 7.0 mm, or iliofemoral vessel conditions such as severe obstructive calcification and severe tortuosity that would preclude safe placement of the 18 Fr introducer sheath or make endovascular access to the aortic valve impossible.
Clinical exclusion criteria:
10.Severe ventricular dysfunction with LVEF less than 20%.
11.Evidence of an acute myocardial infarction within past 30 days before index procedure.
12.Any percutaneous interventional procedure (e.g. PCI with stenting) within 14 days prior to the index procedure.
13.Cerebral vascular accident (CVA) within the past 6 months (= 180 days) of the index procedure.
14.Untreated clinically significant coronary artery disease requiring revascularization.
15.Symptomatic carotid artery disease requiring intervention.
16.History of endocarditis within 12 months of index procedure.
17.Hemodynamic instability (e.g. cardiogenic shock) requiring inotropic support or mechanical heart assistance (e.g. VAD, IABP).
18.Uncontrolled (therapy resistant) atrial fibrillation.
19.Need for emergency surgery for any reason.
20.End stage renal disease requiring chronic dialysis or serum creatinine > 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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause mortality at 30 days
- Secondary Outcome Measures
Name Time Method - Event rates peri- and postoperatively until 12 months follow-up<br>- Device and procedural success<br>- Prosthetic valve performance within one year and annually thereafter