- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02474108
Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement
Pilot, Randomized,Single Blind Trial of Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preservation or appearance of AF(atrial fibrillation) after mitral valve surgery substantially reduce the number of excellent and good results of the operation in the long-term period, causing circulatory insufficiency, increased pulmonary hypertension, increasing the risk of thromboembolic events and stroke.
Significant predictors of AF after surgery are the initial size of the left atrium more than 6.0 cm, stenotic lesions and rheumatic genesis of mitral defect. 80% of patients in this group had AF during the first year after operation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Novosibirsk, Russian Federation, 630055
- MeshalkinRI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- rheumatic mitral valve lesion
- the absence a history of AF
- sinus rhythm
- left atrium size more than 6.0 cm
Exclusion Criteria:
- refusal to participate in the study
- aortic stenosis / regurgitation
- coronary atherosclerosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: without prevention
isolated mitral valve replacement or reconstruction, implantation of cardiac monitor
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in both groups cardiac rhythm will be controlled by a cardiomonitor
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Active Comparator: group of prevention
mitral valve replacement or reconstruction with surgical prevention of AF (concomitant ablation of the left atrium) and implantation of cardiac monitor. Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. |
in both groups cardiac rhythm will be controlled by a cardiomonitor
Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery.
Ablation is performed by radiofrequency electrode or cryoprobe.
Pulmonary veins, posterior wall of the left atrium will be isolated by the scheme box-lesion with additional lines to the mitral valve and appendage of left atrium.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
composite outcome measure of complications
Time Frame: up to 1 year
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up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of participants with freedom from AF according to the long-term ECG monitoring
Time Frame: 1 year
|
1 year
|
transport function of the left atrium according to TTE (transthoracic echo)
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Infections
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Arrhythmias, Cardiac
- Rheumatic Fever
- Heart Diseases
- Atrial Fibrillation
- Rheumatic Diseases
- Rheumatic Heart Disease
Other Study ID Numbers
- SPAF (Other Identifier: Alias Study Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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