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

RECRUITINGN/ASponsored by Na Homolce Hospital
Actively Recruiting
PhaseN/A
SponsorNa Homolce Hospital
Started2022-09-01
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05438862

Summary

The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with conventional guideline-based strategy in asymptomatic patients with severe aortic regurgitation.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

Aortic Valve RegurgitationHeart Disease

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