Status:
RECRUITING
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Lead Sponsor:
Fundación EPIC
Conditions:
Aortic Valve Stenosis
Structural Valve Deterioration
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06049654
Start Date
February 1 2024
End Date
November 1 2026
Last Update
December 19 2025
Active Locations (9)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain, 08907
2
Hospital Clinico San Carlos
Madrid, Spain, 28040
3
Hospital Universitario de La Paz
Madrid, Spain, 28046
4
Hospital Universitario Puerta De Hierro
Majadahonda, Spain, 28222