Comparing early aortic valve surgery to watchful waiting for severe asymptomatic aortic regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the timing of surgical intervention in patients with severe asymptomatic aortic regurgitation. It compares early surgical treatment to a conventional watchful waiting strategy based on cardiac magnetic resonance assessments. The goal is to determine the optimal approach to prevent heart failure and improve outcomes in this patient population. Participants will be monitored for changes in left ventricular function and overall health status.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cardiovascular Center OLV Clinic Aalst
  Aalst, Belgium Recruiting
• Center of Cardiovascular and Transplant Surgery
  Brno, Czechia Recruiting
• University Hospital Hradec Králové
  Hradec Králové, Czechia Recruiting
• 2nd Department of Internal Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
  Prague, Czechia Recruiting
• Na Homolce Hospital
  Prague, Czechia Recruiting
• Nemocnice AGEL Třinec-Podlesí
  Třinec, Czechia Recruiting

Study contacts

• Principal investigator: Radka Kočková, MD, PhD — Na Homolce Hospital
• Study coordinator: Radka Kočková, MD,PhD
• Email: radka.kockova@centrum.cz
• Phone: +420606483586

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.