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

Sponsor: Fundación EPIC

NCT ID: NCT06049654

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
NVT ALLEGRA TAVI System TF (device), EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM (device)
How long the study runs
Study runs about 45 months (dates as stated)
About the drug or intervention
NVT ALLEGRA TAVI System TF — device: Transcatheter aortic valve implantation of a NVT ALLEGRA TAVI System TF in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically · EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM — device: Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
104
Started
2024-02-01
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for aortic valve stenosis
  • • NA - 104 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with aortic valve stenosis

Where?

  • • Manchester - Manchester University NHS Foundation Trust
  • • Newcastle - Freeman Hospital
  • • Swansea - Morriston Hospital, Swansea

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

In the VIVALL.2 study, 104 patients with severely degenerated biological aortic surgical valve accepted for vave-in-valve procedure (transcatheter aortic valve implantation) will be randomized to be treated with the self-expandable supra-annular Allegra or the balloon-expandable intra-annular Edwards systems. The primary end-point will be trans-aortic mean gradient determined by trans-thoracic echocardiography at 30 days. The proportion of patients with moderate or severe prosthesis mismatch at 30 days will be a secondary end-.point. Different countries will participate in the study.

Aortic Valve StenosisStructural Valve Deterioration

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓The patient has heart symptoms and/or deterioration of left ventricular ejection fraction attributable to the...
  • ✓Heart team decision of VIV procedure.

Who cannot take part

  • ✗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.
  • ✗Ongoing sepsis and/or suspicious or diagnosis of endocarditis.
See the full 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).

Where Is This Study? (3 UK sites)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Freeman Hospital

Newcastle, United Kingdom

Recruiting

Morriston Hospital, Swansea

Swansea, United Kingdom

Recruiting

How to Get in Touch

RAÚL MORENO GÓMEZ, MD, PhD

Sponsor contact

CONTACT

0034917277000 raulmorenog@hotmail.com

FUNDACION EPIC

Sponsor contact

CONTACT

0034987876135 iepic@fundacionepic.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-09