Evaluation of the ALLEGRA Plus Heart Valve System for Aortic Stenosis

InvEstigation of the Safety and Performance of the NVT ALLEGRA Plus THV SysteM in Patients With Severe aortIc Stenosis or Failed suRgical Aortic bioprosthEsis

This study is testing a new heart valve system to see if it is safe and effective for people with severe aortic stenosis or those who have had problems with previous heart valve surgeries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 177 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NVT GmbH (Industry-sponsored)
• Locations: 7 sites (Oulu and 6 other locations)
• Trial ID: NCT05804903 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and performance of the ALLEGRA Plus Transcatheter Heart Valve (THV) System in patients suffering from severe aortic stenosis or those with failed surgical aortic bioprosthesis. The study aims to enroll 177 patients and will assess the primary safety endpoint of all-cause mortality or stroke rates at 12 months, alongside the primary performance endpoint of device success at 7 days post-implantation. Participants will be monitored for compliance with study requirements and follow-up visits.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with symptomatic severe calcific aortic stenosis or degeneration of a surgical bioprosthetic valve.

Not a fit: Patients with specific anatomical restrictions or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with severe aortic stenosis, potentially improving their quality of life and survival rates.

How similar studies have performed: Previous studies with similar transcatheter heart valve technologies have shown promising results, indicating potential for success in this approach.

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

Where this trial is running

Oulu and 6 other locations

• Oulu University Hospital — Oulu, Finland (Recruiting)
• Deutsches Herzzentrum Berlin — Berlin, Germany (Not_yet_recruiting)
• Klinika Kardiochirurgii — Gdańsk, Poland (Recruiting)
• III Katedra Kardiologii — Katowice, Poland (Recruiting)
• Reina Sofia Hospital — Córdoba, Spain (Recruiting)
• Hospital La Paz — Madrid, Spain (Recruiting)
• Herzzentrum - Luzerner Kantonsspital — Luzern, Switzerland (Recruiting)

Study contacts

• Study coordinator: Calvin Bahr

Conditions Transcatheter Aortic Valve Implantation; TAVI; Aortic valve stenosis; ALLEGRA Plus; IMPERIA; NVT