Atrial Fibrillation Clinical Trial
Official title:
Pilot, Randomized,Single Blind Trial of Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion
Verified date | September 2017 |
Source | Meshalkin Research Institute of Pathology of Circulation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement
Status | Completed |
Enrollment | 40 |
Est. completion date | October 20, 2016 |
Est. primary completion date | May 5, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | MeshalkinRI | Novosibirsk |
Lead Sponsor | Collaborator |
---|---|
Meshalkin Research Institute of Pathology of Circulation |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | composite outcome measure of complications | up to 1 year | ||
Secondary | number of participants with freedom from AF according to the long-term ECG monitoring | 1 year | ||
Secondary | transport function of the left atrium according to TTE (transthoracic echo) | 1 year |
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