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

Launched by FUNDACIÓN EPIC · Sep 17, 2023

Keywords

ClinConnect Summary

The VIVALL-2 study is a clinical trial designed to compare two types of heart valves used in patients who have had a previous aortic valve replacement that is no longer working well. Specifically, it looks at the Allegra valve, which expands on its own, versus the Edwards valve, which is expanded with a balloon. This study is important for patients with severe issues related to their biological aortic valve, such as narrowing or leaking, and aims to determine which valve system works better for these patients.

To join the trial, participants should be at least 18 years old and have significant problems with their aortic valve that are causing symptoms, like shortness of breath or fatigue. They must also be willing to come back for follow-up tests after 30 days and again after one year. The trial is currently recruiting participants, and it is open to all genders. If you or a loved one are considering participation, it's important to discuss the details with your healthcare team to see if this trial is a good fit.

Gender

ALL

Eligibility 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).