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Stentless mitral valve replacement using autologous pericardium study

Not Applicable
Conditions
Mitral regurgitation
Registration Number
JPRN-UMIN000012659
Lead Sponsor
Sakakibara Heart Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
25
Inclusion Criteria

Not provided

Exclusion Criteria

1. Active malignancy except for in situ cancer 2. Dialysis 3. Participating in other trials 4. Myocardial infarction in the last 6 months 5. Stroke in the last 6 months 6. Previous percutaneous coronary stenting in a month before surgery 7. Concomitant procedures other than tricuspid valve repair, maze operation and pulmonary vein isolation. 8. Severe left ventricular dysfunction (ejection fraction less than 0.30) 9. When excellent outcomes and prognosis are expected with standard prosthetic mitral valve replacement 10. When a principal investigator deems a patient inappropriate as a trial subject

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Residual mitral regurgitation two weeks after surgery
Secondary Outcome Measures
NameTimeMethod
Residual and recurrent mitral regurgitation 12 months after surgery, adverse events in 12 months after surgery, and adverse events in 60 months after surgery.
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