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NCT06049654From ClinicalTrials.govRecruiting

Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

  • Aortic Valve Stenosis
  • Structural Valve Deterioration

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Fundación EPIC
Enrolment target
104
Started
1 February 2024
Main results due
1 November 2027
Study sites
12
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

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.

Exclusion Criteria:

Patients meeting, at least, 1 of the following criteria will be excluded:

* Patients who openly express their refusal to participate in the study.
* Female patients in gestational age.
* 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.
* Ongoing sepsis and/or suspicious or diagnosis of endocarditis.
* 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.
* 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).

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(12)

  • Azienda Ospedaliero- Universitaria di Alessandria

    Alessandria, Italy

    Recruiting

  • ASST Spedali Civili di Brescia

    Brescia, Italy

    Recruiting

  • Azienda Ospedaliera di Perugia

    Perugia, Italy

    Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Spain

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, Spain

    Recruiting

  • Hospital Universitario de La Paz

    Madrid, Spain

    Recruiting

  • Hospital Universitario Puerta De Hierro

    Majadahonda, Spain

    Recruiting

  • Hospital Clínico Universitario de Salamanca

    Salamanca, Spain

    Recruiting

  • Hospital Universitari I Politècnic de La Fe

    Valencia, Spain

    Recruiting

  • Manchester University NHS Foundation Trust

    Manchester, United Kingdom

    Recruiting

  • Freeman Hospital

    Newcastle, United Kingdom

    Recruiting

  • Morriston Hospital, Swansea

    Swansea, United Kingdom

    Recruiting

Showing 12 of 12 sites. 12 of the 12 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06049654. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication | Trialion