Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis

NCT ID: NCT05804903

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-24
• Study Completion Date: 2031-12-31

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.

Conditions

Transcatheter Aortic Valve Implantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis

Group Type: EXPERIMENTAL

(ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis

Intervention Type: DEVICE

Implantation of the ALLEGRA Plus Transcatheter Heart Valve in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis

Interventions

(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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NVT GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oulu University Hospital

Oulu, , Finland

Deutsches Herzzentrum Berlin

Berlin, State of Berlin, Germany

Klinika Kardiochirurgii

Gdansk, , Poland

III Katedra Kardiologii

Katowice, , Poland

Hospital La Paz

Madrid, Madrid, Spain

Reina Sofia Hospital

Córdoba, , Spain

Herzzentrum - Luzerner Kantonsspital

Lucerne, , Switzerland

Countries

Finland; Germany; Poland; Spain; Switzerland

Other Identifiers

NVT06EMP2

Identifier Type: -

Identifier Source: org_study_id