Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey.
Bernard Iung, Victoria Delgado, Raphael Rosenhek...
https://pubmed.ncbi.nlm.nih.gov/31510787Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05438862
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
52 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
Researchers are evaluating the best timing for surgery in patients who have severe aortic regurgitation but do not yet show symptoms. This heart valve condition often affects younger men and can lead to serious heart changes if left untreated. The study compares early surgery guided by detailed heart imaging with the usual approach of monitoring patients and operating only when symptoms or advanced heart changes develop. The study involves two main groups: one will receive early, state-of-the-art aortic valve surgery, including valve-sparing procedures or replacements, scheduled within three months after randomization. The other group will follow a watchful waiting strategy with regular check-ups and surgery only if clear indications arise during follow-up. All patients undergo advanced heart imaging, exercise tests, blood tests, and quality of life questionnaires at set intervals. Participants will have heart magnetic resonance imaging and echocardiography at the start and at 12 months, plus clinical exams and tests every six months. Researchers will monitor heart function, exercise capacity, blood markers, and quality of life. The main outcome is a composite safety and effectiveness measure 12 months after randomization. The study also tracks complications, hospitalizations, and survival over time, with careful follow-up planned through the study duration.
CONDITIONS
Brief Title
Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4 (severe)
- No indication for surgical treatment at the time of enrollment
- Left ventricular ejection fraction greater than 50%
- Absence of more than mild-to-moderate other valve disease or complex congenital heart disease
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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessments
Duration - Up to 1 day
Participants undergo baseline examinations including cardiac magnetic resonance imaging (CMR), echocardiography (ECHO), electrocardiography (ECG), blood tests, exercise stress test (CPET), and quality of life questionnaire.
1 visit (in-person)
Randomization and Early Surgery
Duration - Surgery within 3 months post-randomization
Participants randomized to early surgery undergo aortic valve surgery within 3 months after randomization with follow-up to assess recovery and outcomes.
1 surgical visit plus approximately 6 post-operative visits
Watchful Waiting Follow-up
Duration - Up to 12 months or until surgery is indicated
Participants randomized to watchful waiting are regularly monitored every 6 months with clinical examinations, echocardiography, and blood tests. Surgery is performed if guideline-based indications develop during follow-up.
Biannual visits every 6 months
Follow-up Assessments
Duration - 12 months post-enrollment
All participants undergo repeat CMR, exercise stress testing, and quality of life assessments 12 months after enrollment to evaluate heart function and treatment effects.
1 visit (in-person) plus regular follow-up visits every 6 months
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
Loading map...
Research Team
R
Radka Kočková, MD,PhD
J
Jan Vojáček, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
2021 ESC/EACTS Guidelines for the management of valvular heart disease.
Alec Vahanian, Friedhelm Beyersdorf, Fabien Praz...
https://pubmed.ncbi.nlm.nih.gov/34453165Bicuspid aortic valve: identifying knowledge gaps and rising to the challenge from the International Bicuspid Aortic Valve Consortium (BAVCon).
Hector I Michelena, Siddharth K Prakash, Alessandro Della Corte...
https://pubmed.ncbi.nlm.nih.gov/24958752The relationship of left ventricular geometry and hypertrophy to left ventricular function in valvular heart disease.
B A Carabello
https://pubmed.ncbi.nlm.nih.gov/8563989Influence of collagen network on left ventricular systolic and diastolic function in aortic valve disease.
B Villari, S E Campbell, O M Hess...
https://pubmed.ncbi.nlm.nih.gov/8227808Do Guideline-Based Indications Result in an Outcome Penalty for Patients With Severe Aortic Regurgitation?
Christophe de Meester, Bernhard L Gerber, David Vancraeynest...
https://pubmed.ncbi.nlm.nih.gov/30660551Aortic regurgitation: are we operating too late?
Milind Y Desai
https://pubmed.ncbi.nlm.nih.gov/31240183Mortality and morbidity of aortic regurgitation in clinical practice. A long-term follow-up study.
K S Dujardin, M Enriquez-Sarano, H V Schaff...
https://pubmed.ncbi.nlm.nih.gov/10199882Long-Term Outcomes in Patients With Aortic Regurgitation and Preserved Left Ventricular Ejection Fraction.
Amgad Mentias, Ke Feng, Alaa Alashi...
https://pubmed.ncbi.nlm.nih.gov/27855803Long-term results of aortic valve-sparing operations for aortic root aneurysm.
Tirone E David, Christopher M Feindel, Gary D Webb...
https://pubmed.ncbi.nlm.nih.gov/16872961