Heart Recovery After Surgery for Leaky Aortic Valve and Mitral Leakage
Observes heart recovery after valve surgery in adults with enlarged heart chambers.
Key facts
- Who runs it
- Petrovsky National Research Centre of Surgery
- Where
- Moscow and Voronezh, RussiaSee the 2 sites
- Trial code
- Registry title
- Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 9 May 2024
- Expected to end
- May 2030
- Type of study
- Observational, 4 groups
- Treatments tested
- Not applicable - observational study
- Record updated
- 11 June 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are planned for surgery for long-lasting aortic regurgitation. They must also have functional mitral regurgitation and a very enlarged left ventricle.
- Age
- Over 18 years
- Sex
- All sexes can join
- Disease stage
- Chronic aortic regurgitation with functional mitral regurgitation, and a left ventricle end-diastolic volume of 250 ml or more
- Earlier treatment
- Planned first elective surgery for chronic aortic regurgitation
Main reasons for not taking part
- Infection of the heart valves (infectious endocarditis)
- Earlier heart attack
- Sudden (acute) aortic regurgitation
- Long-lasting or permanent atrial fibrillation
- Pacemaker already implanted
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Age over 18 years
- Planned primary elective surgery for chronic aortic regurgitation
- Presence of functional mitral regurgitation
- End-diastolic volume of the left ventricle \>= 250 ml
Who cannot take part
- Previously diagnosed dilatation of the left ventricle, not associated with the development of aortic regurgitation
- Pregnancy in the first 12 months after surgery
- Acute coronary event diagnosed within 12 months after aortic valve surgery
- Indications for resynchronization therapy or permanent right ventricular pacing in the first 12 months after aortic valve surgery
- History of myocardial infarction
- Indications on simultaneous myocardial revascularisation
- Re-do cardiac surgery for any reason within 12 months after aortic valve surgery
- Infectious endocarditis
- Acute aortic regurgitation of any etiology
- Long-term persistent or permanent form of atrial fibrillation
- Simultaneous participation in other studies
- Presence of implanted pacemakers
- Refusal to sign informed consent
Where in Russia
- Petrovsky National Research Center of SurgeryMoscow, RussiaContact: Eduard Charchyan, professorTaking people
- Voronezh Regional Clinical Hospital No. 1Voronezh, RussiaContact: Andrei BulyninTaking people
About the trial
What the trial wants to find out
Investigators assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse remodeling of the left ventricle (LV) in the postoperative period. It is suggested that functional mitral regurgitation (MR) provides supra-physiological left ventricle volume overload and this fact plays positive role in early-stage post-operative left ventricle volume and function recovery. LV volume, systolic and diastolic function will be monitored with echocardiography (EchoCG) along with life quality in patients with different grades of functional mitral regurgitation secondary to severe chronic aortic insufficiency after surgical treatment of aortic regurgitation.
The 4 groups in the trial
- MR < 2 no MvR
Patients with functional mitral regurgitation grade 0-1, 1 and 1-2 without mitral valve repair (MvR)
Treatment: Not applicable - observational study
- MR >= 2 no MvR
Patients with mitral valve functional regurgitation of grade 2 and more severe without mitral valve repair
Treatment: Not applicable - observational study
- MR < 2 MvR
Patients with functional mitral regurgitation grade 0-1, 1 and 1-2, mitral valve repaired
Treatment: Not applicable - observational study
- MR >= 2 MvR
Patients with mitral valve functional regurgitation of grade 2 and more severe, mitral valve repaired
Treatment: Not applicable - observational study
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment
- Plain-language title
- Heart Recovery After Surgery for Leaky Aortic Valve and Mitral LeakageGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 11 June 2025