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Clinical Trials in the UK / NCT03613246
Active, not recruiting Observational

NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population

NCT03613246 · tracked via the Priya Life Science UK tracker
Sponsor
NVT GmbH
Phase
Observational
Started
2019-02-20
Last updated
2025-11-17

Condition(s) studied

Transcatheter Aortic Valve Implantation

Study summary

The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Symptomatic degeneration of severe calcified aortic heart valve OR failing surgical aortic bioprosthetic valve 2. Acceptable candidate for elective treatment with the ALLEGRA TAVI System TF (according to the most recent version of the ALLEGRA Instructions For Use) 3. High risk for surgery as assessed by the heart team 4. Has signed the Patient Informed Consent Form \>= 18 years Exclusion Criteria: General: 1. Echocardiographic evidence of intracardiac thrombus or vegetation 2. Significant aortic disease such as severe obstructive calcification or marked tortuosity or kinking which will preclude a safe advancement of the ALLEGRA TAVI System TF 3. Iliofemoral vessel conditions such as severe obstructive calcification, severe tortuosity or kinking that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access to the aortic valve impossible 4. Severe ventricular dysfunction with LVEF \<20% 5. Evidence of active endocarditis or other acute infections 6. Renal failure requiring continuous renal replacement therapy 7. 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 8. Life expectancy ≤ 12 months due to other medical illness 9. Currently participating in another investigational drug or device study Patients with native aortic valve disease: 1. Unicuspid or bicuspid aortic valve 2. Non-calcified aortic stenosis 3. Combined aortic valve disease with predominant aortic regurgitation \> 3 4. Distance between aortic valve basal plane and the orifice of the lowest coronary artery \< 8 mm Patients with degenerated surgical bioprosthetic aortic valves: 1. Low position of the coronary ostia, especially in combination with shallow sinuses 2. Internal diameter of the bioprosthesis is ≤16 mm or \>28 mm 3. Partially detached leaflets that in the aortic position may obstruct a coronary ostium

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Oulu University Hospital Oulu Finland
Herz- und Gefäßzentrum Bad Bevensen Bad Bevensen Germany
Schuechtermann-klinik Bad Rothenfelde Germany
Kath. Marienkrankenhaus Hamburg Germany
MH Hannover Hanover Germany
SLK-Kliniken Heilbronn Heilbronn Germany
Ospedale San Raffaele Milan Italy
Clinica Mediterranea Neapel Naples Italy
Heartcentre Catharina Hospital Eindhoven Eindhoven Netherlands
Hospital Universitario La Paz Madrid Spain
Hospital Universitario Virgen de la Victoria Málaga Spain
Hospital Universitario de Salamanca Salamanca Spain
Hospital Alvaro Cunqueiro Vigo Spain
Morriston Hospital Swansea United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03613246 on ClinicalTrials.gov ↗ ← All trials in the UK