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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNa Homolce Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • State of art aortic valve surgery

Treatment groups

217 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Na Homolce Hospital

Lead sponsor

University Hospital Hradec Kralove

Collaborator

Centre of Cardiovascular and Transplantation Surgery, Czech Republic

Collaborator

St. Anne's University Hospital Brno, Czech Republic

Collaborator

VZW Cardiovascular Research Center Aalst

Collaborator

General University Hospital, Prague

Collaborator

University Clinical Centre of Republic of Srpska

Collaborator

AGEL Třinec-Podlesí Hospital

Collaborator