Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05438862

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

Led by Na Homolce Hospital · Updated on 2026-02-17

217

Participants Needed

8

Research Sites

278 weeks

Total Duration

On this page

Sponsors

N

Na Homolce Hospital

Lead Sponsor

U

University Hospital Hradec Kralove

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) or grade 4 (severe)
  • No indication for surgical treatment at the time of enrollment
  • Left ventricular ejection fraction greater than 50%
  • No more than mild-to-moderate other valve disease or complex congenital heart disease
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Clearance creatinine less than 30 mL/min
  • Contraindications for magnetic resonance imaging such as implanted active devices, incompatible ferromagnetic implants, cerebral aneurysm clips, or metallic fragments near sensitive tissues
  • Pregnancy
  • Permanent atrial fibrillation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Cardiovascular Center OLV Clinic Aalst

Aalst, Belgium, 9300

Actively Recruiting

2

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

Brno, Czechia, 656 91

Active, Not Recruiting

3

Center of Cardiovascular and Transplant Surgery

Brno, Czechia, 65691

Actively Recruiting

4

University Hospital Hradec Králové

Hradec Králové, Czechia, 50005

Actively Recruiting

5

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

Prague, Czechia, 128 08

Actively Recruiting

6

Na Homolce Hospital

Prague, Czechia, 150 30

Actively Recruiting

7

Nemocnice AGEL Třinec-Podlesí

Třinec, Czechia, 73961

Actively Recruiting

8

University Clinical Center of Serbia

Belgrade, Serbia, 11000

Actively Recruiting

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Research Team

R

Radka Kočková, MD,PhD

CONTACT

J

Jan Vojáček, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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