Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
NCT ID: NCT06805253
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-05-09
2030-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MR < 2 no MvR
Patients with functional mitral regurgitation grade 0-1, 1 and 1-2 without mitral valve repair (MvR)
Not applicable - observational study
observation only
MR >= 2 no MvR
Patients with mitral valve functional regurgitation of grade 2 and more severe without mitral valve repair
Not applicable - observational study
observation only
MR < 2 MvR
Patients with functional mitral regurgitation grade 0-1, 1 and 1-2, mitral valve repaired
Not applicable - observational study
observation only
MR >= 2 MvR
Patients with mitral valve functional regurgitation of grade 2 and more severe, mitral valve repaired
Not applicable - observational study
observation only
Interventions
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Not applicable - observational study
observation only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned primary elective surgery for chronic aortic regurgitation
* Presence of functional mitral regurgitation
* End-diastolic volume of the left ventricle \>= 250 ml
Exclusion Criteria
* History of myocardial infarction
* Indications on simultaneous myocardial revascularisation
* Acute aortic regurgitation of any etiology
* Previously diagnosed dilatation of the left ventricle, not associated with the development of aortic regurgitation
* Long-term persistent or permanent form of atrial fibrillation
* Pregnancy in the first 12 months after surgery
* Simultaneous participation in other studies
* Presence of implanted pacemakers
* Refusal to sign informed consent
* 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
* Re-do cardiac surgery for any reason within 12 months after aortic valve surgery
18 Years
ALL
No
Sponsors
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Voronezh regional clinical hospital #1
UNKNOWN
Petrovsky National Research Centre of Surgery
OTHER
Responsible Party
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Locations
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Petrovsky National Research Center of Surgery
Moscow, , Russia
Voronezh Regional Clinical Hospital No. 1
Voronezh, , Russia
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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173538086
Identifier Type: -
Identifier Source: org_study_id
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