Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication (NCT06049654) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Italy, Spain, United Kingdom104 participantsStarted 2024-02-01
Plain-language 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 biological aortic surgical valve.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Patient…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).