JPRN-jRCT1032180087
Suspended
N/A
Stentless mitral valve replacement using autologous pericardium study - Stentless mitral valve replacement using autologous pericardium study
Shimokawa Tomoki0 sites25 target enrollmentJanuary 17, 2019
ConditionsMitral regurgitation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mitral regurgitation
- Sponsor
- Shimokawa Tomoki
- Enrollment
- 25
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •We include patients who meet all of the followings.
- •1\. Diagnosis of mitral regurgitation
- •2\. Mitral valve disease that meets at least one of following conditions and is indicated for surgery
- •(1\) Symptomatic acute severe MR
- •(2\) Chronic severe MR and NYHA functional class II, III or IV symptoms in the absence of severe LV dysfunction (severe LV dysfunction is defined as ejection fraction less than 0\.30\).
- •(3\) Asymptomatic chronic severe MR with mild to moderate LV dysfunction, ejection fraction 0\.30 to 0\.60, and/or end\-systolic dimension greater than or equal to 40 mm.
- •3\. Advamced mitral valve disease that standard mitral valve repair is difficult for and is unlikely to present durable results for. (must meet at least one of the followings)
- •(1\) Redo mitral valve surgery 6 months or longer after the previous mitral valve surgery.
- •(2\) Infective endocarditis extending over the anterior and posterior leaflets
- •4\. Written informed consent is obtained from the patient or his/her parental authority.
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
Outcomes
Primary Outcomes
Not specified
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