Loading clinical trials...

COMPLETEDNA

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

Investigation of the Safety and Performance of the NVT ALLEGRA THV System With a New Delivery System in Patients With Severe Calcified Aortic Stenosis or Failed Surgical Aortic Bioprosthesis

NCT05478161•NVT GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

•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 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
+21 more criteria

Locations (11)

Schüchtermann Klinik

Bad Rothenfelde, Lower Saxony, Germany

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, Germany

UKSH, Campus Lübeck

Lübeck, Germany

Catharina Hospital

Eindhoven, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Hospital Universitari de Bellvitge

Barcelona, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Key Dates

Start Date

January 24, 2023

Primary Completion Date

December 20, 2023

Completion Date

December 17, 2024

Last Updated

February 24, 2026

Enrollment

137

ACTUAL participants

Conditions

Transcatheter Aortic Valve Implantation

Interventions

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

DEVICE

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

NCT07366671

TAVI(Transcatheter Aortic Valve Implantation)Aortic Valve Disease

View study

RECRUITING

The EASE-IT CT Registry

NCT05750173

Transcatheter Aortic Valve Implantation (TAVI)

View study

RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

The EASE-IT CT Registry

Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation

Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis（ECHO-TAVR）

Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)

The Sentinel Registry