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

NCT03613246 | Active Not Recruiting

• 1 other identifier: NVT04FOL
• Study Type: observational
• Target: 346
• Locations: 6 countries
• Sites: 14

Brief 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.

Conditions

Transcatheter Aortic Valve Implantation

Keywords

TAVI; Aortic valve stenosis; ALLEGRA

Outcome Measures

Primary Outcomes (1)

• Cardiovascular death

  30 days post-index procedure

Secondary Outcomes (8)

• All-cause mortality

  up to five years

• Technical success of implantation

  day of procedure

• Assesment of NYHA classification

  30 days, 12 month, 24 month, 36 month, 48 month, 60 month

• Safety profile according to VARC II

  30 days

• In-hospital mortality

  date of procedure till date of estimated discharge, assessed up to two weeks

Study Arms (2)

Cohort 1: Patients who undergo TAVI for symptomatic severe stenosed aortic heart valves

Cohort 2:

patients undergoing a VIV procedure in failing surgical bioprostheses.

Eligibility Criteria

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

Study Population

Symptomatic patients with elevated surgical risk and candidate for TAVI with severe calcified and stenotic aortic valves or failing surgical bioprosthetic aortic valves.

You may qualify if:

• Symptomatic degeneration of severe calcified aortic heart valve OR failing surgical aortic bioprosthetic valve
• Acceptable candidate for elective treatment with the ALLEGRA TAVI System TF (according to the most recent version of the ALLEGRA Instructions For Use)
• High risk for surgery as assessed by the heart team
• Has signed the Patient Informed Consent Form \>= 18 years

You may not qualify if:

• General:
• Echocardiographic evidence of intracardiac thrombus or vegetation
• 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
• 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
• Severe ventricular dysfunction with LVEF \<20%
• Evidence of active endocarditis or other acute infections
• Renal failure requiring continuous renal replacement therapy
• 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
• Life expectancy ≤ 12 months due to other medical illness
• Currently participating in another investigational drug or device study
• Patients with native aortic valve disease:
• Unicuspid or bicuspid aortic valve
• Non-calcified aortic stenosis
• Combined aortic valve disease with predominant aortic regurgitation \> 3
• Distance between aortic valve basal plane and the orifice of the lowest coronary artery \< 8 mm

Sponsors & Collaborators

• NVT GmbH: lead

Study Sites (14)

Oulu University Hospital

Oulu, 90220, Finland

Location

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

Schuechtermann-klinik

Bad Rothenfelde, Germany

Location

Kath. Marienkrankenhaus

Hamburg, 22087, Germany

Location

MH Hannover

Hanover, 30625, Germany

Location

SLK-Kliniken Heilbronn

Heilbronn, 74078, Germany

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Clinica Mediterranea Neapel

Naples, Italy

Location

Heartcentre Catharina Hospital Eindhoven

Eindhoven, 5623 EJ, Netherlands

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, 36213, Spain

Location

Morriston Hospital

Swansea, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Ulrich Schäfer, MD

  Herz-und Gefäßzentrum Bad Bevensen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 3, 2018
• Study Start: February 20, 2019
• Primary Completion: December 20, 2024
• Study Completion (Estimated): January 26, 2029
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); IT (2); FI (1); NL (1); GB (1); ES (4)