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

Plain Language Summary

Simplified for easier understanding

This study compares two strategies for treating severe asymptomatic aortic regurgitation — a "leaky" heart valve where blood flows backwards into the heart — in people who feel no symptoms yet. It compares early surgery to a watchful waiting approach with regular monitoring. You may be eligible if: - You are 18 or older - You have moderate-to-severe or severe aortic regurgitation (grade 3 or 4) with no symptoms - Your heart pumping function (LVEF) is above 50% - You have no current indication for surgery - You have at most mild-to-moderate disease in other heart valves You may NOT be eligible if: - You are under 18 - Your kidney function is severely reduced (creatinine clearance below 30 mL/min) - You have a contraindication to MRI (pacemaker, certain metal implants, cerebral aneurysm clip) - You are pregnant - You have permanent atrial fibrillation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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