Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation

Launched by NA HOMOLCE HOSPITAL · Jun 25, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the best time for surgery in patients with severe aortic regurgitation who do not have any symptoms. Aortic regurgitation is a condition where the heart's aortic valve doesn't close properly, causing blood to flow backward into the heart. In this study, researchers will compare two approaches: early surgery versus a "watchful waiting" strategy, which means monitoring the patient closely without immediate surgery. The goal is to see which method leads to better outcomes for patients.

To participate in this trial, you need to be between 65 and 74 years old and have been diagnosed with moderate to severe aortic regurgitation, but you should not have any symptoms or need surgery at the time of enrollment. You also need to have a good heart function, indicated by a specific measurement called ejection fraction, and not have other significant heart problems. If you join the study, you can expect regular check-ups and assessments, including advanced imaging tests to monitor your heart’s condition. This trial is currently recruiting participants, and all genders are welcome. If you're considering participating, it’s a good idea to discuss it with your healthcare provider to see if it’s a good fit for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4 (severe)
• • No indication for the surgical treatment at the time of enrolment
• • LV ejection fraction \>50%
• • Absence of more than mild-to-moderate concomitant valve disease or complex congenital heart disease
• Exclusion Criteria:
• • Age \<18 years
• • Clearance Creatinine \<30 mL/min
• • Contraindication for magnetic resonance (implanted active device, ferromagnetic implant incompatible with magnetic resonance scanner, cerebral aneurysm clip, metallic fragment in the eye or near sensitive tissue)
• • Pregnancy
• • Permanent atrial fibrillation.