Transcatheter Aortic Valve Implantation
Conditions
Keywords
TAVI, Aortic valve stenosis, ALLEGRA Plus, IMPERIA, NVT
Brief summary
The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System. The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months. And the primary performance endpoint is device success at 7 days. Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 177 patients need to be enrolled in the study.
Interventions
DEVICE(ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
Implantation of the ALLEGRA Plus Transcatheter Heart Valve in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
Sponsors
NVT GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 +/- insufficiency) on site-reported 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
Patient will not be included if ANY one of the following conditions exists: General: 1. Mean aortic annulus diameter as measured by pre-procedural 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 Plus 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. Porcelain aorta 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 (site-reported) 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. Hypertrophic obstructive cardiomyopathy 23. Pregnancy or intend to become pregnant during study participation Specific exclusions in patients with native aortic valve disease (site-reported): 24. Unicuspid or bicuspid aortic valve 25. Non-calcified aortic stenosis 26. Identified risk of coronary occlusion due to Sinus of Valsalva anatomy and/or bulky calcified aortic valve leaflets in close proximity to coronary ostia Specific exclusions in patients with degenerated surgical bioprosthetic aortic valves (valve-in-valve) (site-reported): 27. High risk of coronary occlusion 28. Partially detached leaflets that may obstruct a coronary ostium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of all-cause mortality or stroke rates | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality rate | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | — |
| Cardiovascular mortality rate | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | — |
| Any stroke rate | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | — |
| Transient ischemic attack rate | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | — |
| Device success rate | 30 days | Device success at 30 days (In-hospital may be used if 30-day data are not available): * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve‡(mean gradient\<20 mmHg, peakvelocity\<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation |
| Effective orifice area (EOA) as assessed by transthoracic echocardiogram (TTE) | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | as determined by an independent Echo Core Lab |
| Transvalvular mean and peak pressure gradient as assessed by transthoracic echocardiogram (TTE) | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | as determined by an independent Echo Core Lab |
| Transvalvular mean and peak pressure gradient as assessed by transthoracic | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | as determined by an independent Echo Core Lab |
| NYHA classification | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | — |
| Life-threatening/major bleeding (BARC 3b or more) | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | — |
| Major vascular complications according to VARC-3 | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | — |
| Early safety profile according to VARC-3 | 30 days | — |
| Quality of life as assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | Assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Patients are asked questions about physical limitation, symptom frequency, quality of life, and social limitation. Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health. |
| New pacemaker implantation rate | 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years | — |
Countries
Finland, Germany, Poland, Spain, Switzerland
Outcome results
None listed