Under construction – not a live service
Sign in
Taking people in ItalyNo phase

Comparing two heart valve types for worn-out surgical aortic valves

Compares Allegra and Sapien valves for worn-out surgical aortic valves.

Key facts

Who runs it
Fundación EPIC
Where
Alessandria, Brescia, and Perugia, ItalySee the 3 sitesAlso in 2 other countries, 9 sites
Trial code
Registry title
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Status
Recruiting
People taking part
104 people, planned
Started
1 Feb 2024
Expected to end
1 Nov 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • NVT ALLEGRA TAVI System TF
  • EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
Record updated
24 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose biological aortic valve, placed in an earlier surgery, has badly worn out. They will get a new valve through a catheter inside the old one (valve-in-valve). People are assigned by chance to the Allegra valve or the Edwards Sapien valve.

Age
18 years or older
Sex
All sexes
Disease stage
Severe wear of a surgically placed biological aortic valve: severe narrowing (valve area < 1.0 cm2) and/or severe leaking. There must be heart symptoms and/or weaker heart pumping caused by the valve. The heart team must have decided on a valve-in-valve procedure.
Earlier treatment
Must have had a biological aortic valve placed by surgery.

Main reasons for not taking part

  • Women who are able to become pregnant
  • Blood clot, or suspected clot, on the old valve
  • Active blood infection, or suspected or known infection of the heart lining (endocarditis)
  • Expected to live < 1 year because of other, non-heart illnesses
  • Old valve inner diameter > 27 mm, or groin artery too small for an 18F sheath

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Patients meeting ALL the following criteria will be included:
  • Patients aged ≥ 18 years
  • Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area < 1.0 cm2) and/or severe valve regurgitation
  • The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease
  • Heart team decision of VIV procedure
  • Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year

Who cannot take part

  • Presence or suspicious of biological aortic valve thrombosis
  • Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
  • Patients whose life expectancy is < 1 year due to non-cardiac comorbid conditions
  • Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams
  • Female patients in gestational age
  • Patients meeting, at least, 1 of the following criteria will be excluded:
  • Patients who openly express their refusal to participate in the study
  • Ongoing sepsis and/or suspicious or diagnosis of endocarditis
  • True inner diameter of the prosthetic valve > 27 mm
  • Transfemoral access inadequate to accommodate an 18F sheath
  • Patients included in other clinical trials (excluding registries)

Where in Italy

Also in 2 other countries, 9 sites

  • Azienda Ospedaliero- Universitaria di AlessandriaAlessandria, ItalyContact: RAÚL MORENO GÓMEZ, MD, PhDTaking people
  • ASST Spedali Civili di BresciaBrescia, ItalyContact: RAÚL MORENO GÓMEZ, MD, PhDTaking people
  • Azienda Ospedaliera di PerugiaPerugia, ItalyContact: RAÚL MORENO GÓMEZ, MD, PhDTaking people

About the trial

What the trial wants to find out

The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.

The 2 groups in the trial

  • NVT ALLEGRA System TFExisting treatment, for comparison

    Treatment: NVT ALLEGRA TAVI System TF

  • EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEMTreatment being tested

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Plain-language title
Comparing two heart valve types for worn-out surgical aortic valvesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
24 September 2026