Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis

NCT05478161 | Completed DMC

• 1 other identifier: NVT05EMP
• Study Type: interventional
• Target: 137
• Locations: 3 countries
• Sites: 11

Brief Summary

The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System. The primary endpoint is device success rate at 7 days (discharge from index procedure or 7 days post implant, whichever comes first), as defined by VARC 2. Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 107 patients need to be enrolled in the study.

Conditions

Transcatheter Aortic Valve Implantation

Keywords

TAVI; Aortic valve stenosis; ALLEGRA; IMPERIA

Outcome Measures

Primary Outcomes (1)

• Device success at 7 days

  * Absence of procedural mortality AND * Correct positioning of a single device in the proper anatomical location (site-reported) AND * Intended performance of the prosthetic heart valve (as determined by an independent Echo Core Lab at discharge from index procedure or 7 days post implant, whichever comes first) * Indexed Effective Orifice Area (iEOA) \> 0.85 cm2/m2 for BMI \< 30kg/m2 and iEOA \> 0.70 cm2/m2 for BMI ≥ 30kg/m2 * Mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s * No moderate or severe prosthetic valve regurgitation

  7 day

Secondary Outcomes (14)

• All-cause mortality

  up to 12 months

• Cardiovascular mortality

  up to 12 months

• All stroke

  up to 12 months

• TIA

  up to 12 months

• Procedural success

  assessed immediately after the procedure

Study Arms (1)

treatment

EXPERIMENTAL

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

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

Interventions

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

Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis

treatment

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:

• 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 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)
• 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)

Sponsors & Collaborators

• NVT GmbH: lead

Study Sites (11)

Schüchtermann Klinik

Bad Rothenfelde, Lower Saxony, 49214, Germany

Location

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, Germany

Location

UKSH, Campus Lübeck

Lübeck, Germany

Location

Catharina Hospital

Eindhoven, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, 36213, Spain

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: July 19, 2022
• First Posted: July 28, 2022
• Study Start: January 24, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 17, 2024
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

DE (3); ES (5); NL (3)