Status:
RECRUITING
Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation
Lead Sponsor:
Na Homolce Hospital
Collaborating Sponsors:
University Hospital Hradec Kralove
Centre of Cardiovascular and Transplantation Surgery, Czech Republic
Conditions:
Aortic Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Introduction: Aortic regurgitation (AR) is the third most frequent valvular heart disease in Western countries affecting rather young patients, mostly men. The degenerative process on the trileaflet ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT05438862
Start Date
September 1 2022
End Date
December 31 2027
Last Update
May 30 2025
Active Locations (7)
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1
Cardiovascular Center OLV Clinic Aalst
Aalst, Belgium, 9300
2
International Clinical Research Center, St. Anne´s University Hospital Brno
Brno, Czechia, 656 91
3
Center of Cardiovascular and Transplant Surgery
Brno, Czechia, 65691
4
University Hospital Hradec Králové
Hradec Králové, Czechia, 50005