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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (3 UK sites)
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Morriston Hospital, Swansea
Swansea, United Kingdom
How to Get in Touch
RAÚL MORENO GÓMEZ, MD, PhD
Sponsor contactCONTACT
FUNDACION EPIC
Sponsor contactCONTACT
