Actively Recruiting
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Led by Fundación EPIC · Updated on 2025-12-19
104
Participants Needed
9
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 65 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
- Patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction due to the aortic valve disease
- Heart team decision for valve-in-valve procedure
- Patient is willing to return at 30 days for echocardiography and to be contacted clinically at 1 year
You will not qualify if you...
- Patients who openly refuse to participate in the study
- Female patients who are pregnant
- Presence or suspicion of biological aortic valve thrombosis
- Known allergy or contraindication to antithrombotic therapy, nitinol, or contrast media that cannot be pre-treated
- Ongoing sepsis or suspicion/diagnosis of endocarditis
- Life expectancy less than 1 year due to non-cardiac conditions
- Medical, social, or psychological issues preventing consent or follow-up adherence
- Prosthetic valve inner diameter greater than 27 mm
- Inadequate transfemoral access for an 18F sheath
- Participation in other clinical trials (except registries)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain, 08907
Actively Recruiting
2
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
3
Hospital Universitario de La Paz
Madrid, Spain, 28046
Actively Recruiting
4
Hospital Universitario Puerta De Hierro
Majadahonda, Spain, 28222
Actively Recruiting
5
Hospital Clínico Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
6
Hospital Universitari I Politècnic de La Fe
Valencia, Spain, 46026
Actively Recruiting
7
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
8
Freeman Hospital
Newcastle, United Kingdom
Actively Recruiting
9
Morriston Hospital, Swansea
Swansea, United Kingdom
Actively Recruiting
Research Team
R
RAÚL MORENO GÓMEZ, MD, PhD
CONTACT
F
FUNDACION EPIC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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