Early Aortic Valve Surgery Versus Watchful Waiting Strategy in Severe Asymptomatic Aortic Regurgitation
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
Cardiovascular Center OLV Clinic Aalst
RECRUITING
Aalst
Serbia
University Clinical Center of Serbia
RECRUITING
Belgrade
Contact Information
Primary
Radka Kočková, MD,PhD
radka.kockova@centrum.cz
+420606483586
Backup
Jan Vojáček, MD, PhD
jan.vojacek1@fnhk.cz
+420777095921
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 217
Treatments
Experimental: Early surgery
Early surgical treatment, state of art aortic valve surgery.
No_intervention: Watchful waiting
Watchful waiting strategy, regular follow-up of patients with severe valve disease. Guideline-based indication for surgery only during the follow-up.
Related Therapeutic Areas
Sponsors
Collaborators: General University Hospital, Prague, University Hospital Hradec Kralove, Centre of Cardiovascular and Transplantation Surgery, Czech Republic, St. Anne's University Hospital Brno, Czech Republic, University Clinical Centre of Republic of Srpska, VZW Cardiovascular Research Center Aalst
Leads: Na Homolce Hospital