Clinical trial NCT05804903: Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
Official title: InvEstigation of the Safety and Performance of the NVT ALLEGRA Plus THV SysteM in Patients With Severe aortIc Stenosis or Failed suRgical Aortic bioprosthEsis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcatheter Aortic Valve Implantation
Keywords: TAVI
Aortic valve stenosis
ALLEGRA Plus
IMPERIA
NVT
Lead sponsor: NVT GmbH
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of all-cause mortality or stroke rates
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality rate
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: Cardiovascular mortality rate
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: Any stroke rate
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: Transient ischemic attack rate
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: Device success rate
timeFrame: 30 days
measure: Effective orifice area (EOA) as assessed by transthoracic echocardiogram (TTE)
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: Transvalvular mean and peak pressure gradient as assessed by transthoracic echocardiogram (TTE)
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: Transvalvular mean and peak pressure gradient as assessed by transthoracic
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: NYHA classification
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: Life-threatening/major bleeding (BARC 3b or more)
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: Major vascular complications according to VARC-3
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: Early safety profile according to VARC-3
timeFrame: 30 days
measure: Quality of life as assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
measure: New pacemaker implantation rate
timeFrame: 7 days, 30 days, 6 months, 12 months, 2 years, 3 years , 4 years, 5 years
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Gdańsk
country: Poland
facility: Klinika Kardiochirurgii
city: Katowice
country: Poland
facility: III Katedra Kardiologii
city: Córdoba
country: Spain
facility: Reina Sofia Hospital
city: Madrid
country: Spain
facility: Hospital La Paz
city: Luzern
country: Switzerland
facility: Herzzentrum - Luzerner Kantonsspital
Study officials:
References: