RecruitingNot ApplicableNCT05438862

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

Early Aortic Valve Surgery Versus Watchful Waiting Strategy in Severe Asymptomatic Aortic Regurgitation


Sponsor

Na Homolce Hospital

Enrollment

217 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

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Interventions

PROCEDUREState of art aortic valve surgery

Optimal surgical treatment (aortic valve-sparing surgery, aortic valve replacement, Ross procedure).


Locations(8)

Cardiovascular Center OLV Clinic Aalst

Aalst, Belgium

International Clinical Research Center, St. Anne´s University Hospital Brno

Brno, Czechia

Center of Cardiovascular and Transplant Surgery

Brno, Czechia

University Hospital Hradec Králové

Hradec Králové, Czechia

2nd Department of Internal Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague

Prague, Czechia

Na Homolce Hospital

Prague, Czechia

Nemocnice AGEL Třinec-Podlesí

Třinec, Czechia

University Clinical Center of Serbia

Belgrade, Serbia

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NCT05438862


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