InvEstigation of the safety and perforMance of the NVT ALLEGRA THV System with a new delivery system in Patients with severe calcified aortIc stenosis or failed suRgical aortic bioprosthEsis
- Conditions
- severe calcified aortic stenosis or failed surgical aortic bioprosthesis10046973
- Registration Number
- NL-OMON53564
- Lead Sponsor
- VT GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria:
Patients will be included if ALL of the following criteria are met:
1. Symptomatic severe calcific stenosis of a native aortic valve with an AVA
<=1.0 cm2 (or AVA index <=0.6 cm2/m2), AND mean aortic pressure gradient >= 40mmHg
OR maximal transaortic velocity >=4.0m/s OR Doppler velocity index <=0.25 on
site-reported echocardiography OR symptomatic patients with degeneration of a
surgical bioprosthetic valve (stenosis and/or insufficiency) on sitereported
echocardiography
2. Local multi-disciplinary Heart Team and Central Screening Committee (CSC)
agree on indication and eligibility for TAVI
3. Age >=18 years
4. Patient has signed the Patient Informed Consent Form
5. Patient is willing and able to comply with requirements of the study,
including all follow-up visits
Exclusion Criteria
General:
1. Mean aortic annulus diameter as measured by preprocedural CT or internal
diameter of the bioprosthesis is <16.5 mm or >27 mm
2. Echocardiographic evidence of intracardiac thrombus or vegetation
(site-reported)
3. Significant disease of the aorta that would preclude safe advancement of the
ALLEGRA THV System
4. Severe ilio-femoral vessel disease that would preclude safe placement of an
18 Fr introducer sheath or make endovascular access impossible
5. Severe tricuspid regurgitation and/or failing right heart (site-reported)
6. Severe left ventricular dysfunction with ejection fraction (EF) <20%
(site-reported)
7. Evidence of active endocarditis or other acute infections
8. Renal failure requiring continuous renal replacement therapy
9. Untreated clinically significant coronary artery disease requiring
revascularization
10. Any percutaneous interventional procedure (e.g. PCI with stenting) within
14 days prior of the index procedure
11. Acute MI <=30 days prior to the index procedure
12. Symptomatic carotid or vertebral artery disease requiring intervention or
carotid/vertebral intervention within the preceding 45 days
13. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) <=6 months
or prior CVA with moderate or severe disability (e.g. modified Rankin scale
score >2)
14. History of bleeding diathesis or coagulopathy; acute blood dyscrasias as
defined: thrombocytopenia (platelets <80,000/µl), acute anemia (hemoglobin <10
g/dl), leukopenia (WBC <3000/ µl)
15. Active peptic ulcer or gastrointestinal (GI) bleeding <=3 months
16. Severe (greater than 3+) mitral insufficiency (sitereported)
16a. Pre-existing prosthetic heart valve in any position other than aortic
17. Uncontrolled atrial fibrillation
18. Required emergency surgery for any reason
19. Known hypersensitivity to contrast media, which cannot be adequately
pre-medicated or contraindication to anticoagulant or anti-platelet medication
or to nitinol alloy or to bovine tissue
20. Life expectancy <=12 months due to other medical illness
21. Currently participating in another investigational drug or device study
22. Pregnancy or intend to become pregnant during study participation
Specific exclusions in patients with native aortic valve disease
(site-reported):
23. Unicuspid or bicuspid aortic valve
24. Non-calcified aortic stenosis
25. Predominant aortic regurgitation > grade 3
26. Distance between native aortic valve basal plane and the orifice of the
lowest coronary artery <8 mm
Specific exclusions in patients with degenerated surgical bioprosthetic aortic
valves (valve-in-valve) (site-reported):
27. Low position of the coronary ostia, especially in combination with shallow
sinuses (high risk of coronary occlusion)
28. Partially detached leaflets that may obstruct a coronary ostium
29. Para-valvular regurgitation of a surgical bioprosthesis (site-reported)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Device success at 7 days, defined as<br /><br>• Absence of procedural mortality AND<br /><br>• Correct positioning of a single device in the proper anatomical location<br /><br>(site-reported) AND<br /><br>• Intended performance of the prosthetic heart valve (as determined by an<br /><br>independent Echo Core Lab at discharge from index procedure or 7 days post<br /><br>implant, whichever comes first)<br /><br>• Indexed Effective Orifice Area (iEOA) > 0.85 cm2/m2 for BMI < 30kg/m2 and<br /><br>iEOA > 0.70 cm2/m2 for BMI >= 30kg/m2<br /><br>• Mean aortic valve gradient <20 mmHg or peak velocity <3 m/s<br /><br>• No moderate or severe prosthetic valve regurgitation</p><br>
- Secondary Outcome Measures
Name Time Method