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

NCT05804903 | Suspended DMC

• 1 other identifier: NVT06EMP2
• Study Type: interventional
• Target: 177
• Locations: 5 countries
• Sites: 7

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

Keywords

TAVI; Aortic valve stenosis; ALLEGRA Plus; IMPERIA; NVT

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause mortality or stroke rates

  12 months

Secondary Outcomes (14)

• 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

Study Arms (1)

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

EXPERIMENTAL

Device: (ALLEGRA Plus Transcatheter Heart Valve) TAVI 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 DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Local multi-disciplinary Heart Team and Central Screening Committee (CSC) agree on indication and eligibility for TAVI
• Age ≥18 years
• Patient has signed the Patient Informed Consent Form
• Patient is willing and able to comply with requirements of the study, including all follow-up visits

You may not qualify if:

• Patient will not be included if ANY one of the following conditions exists:
• General:
• Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is \<16.5 mm or \>27 mm
• Echocardiographic evidence of intracardiac thrombus or vegetation (site-reported)
• Significant disease of the aorta that would preclude safe advancement of the ALLEGRA Plus THV System
• Severe ilio-femoral vessel disease that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access impossible
• Porcelain aorta
• Severe left ventricular dysfunction with ejection fraction (EF) \<20% (site-reported)
• Evidence of active endocarditis or other acute infections
• Renal failure requiring continuous renal replacement therapy
• Untreated clinically significant coronary artery disease requiring revascularization
• Any percutaneous interventional procedure (e.g. PCI with stenting) within 14 days prior of the index procedure
• Acute MI ≤30 days prior to the index procedure
• Symptomatic carotid or vertebral artery disease requiring intervention or carotid/vertebral intervention within the preceding 45 days
• 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)

Sponsors & Collaborators

• NVT GmbH: lead

Study Sites (7)

Oulu University Hospital

Oulu, 90220, Finland

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Klinika Kardiochirurgii

Gdansk, 80-214, Poland

Location

III Katedra Kardiologii

Katowice, 40-635, Poland

Location

Reina Sofia Hospital

Córdoba, 14004, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Herzzentrum - Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 7, 2023
• Study Start: November 24, 2023
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 1, 2030
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

ES (2); FI (1); DE (1); CH (1); PL (2)