Unique ID issued by UMIN | UMIN000021445 |
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Receipt number | R000024675 |
Scientific Title | Stentless mitral valve replacement using autologous pericardium study |
Date of disclosure of the study information | 2016/04/01 |
Last modified on | 2019/11/05 17:53:57 |
Stentless mitral valve replacement using autologous pericardium study
Stentless mitral valve replacement using autologous pericardium study
Stentless mitral valve replacement using autologous pericardium study
Stentless mitral valve replacement using autologous pericardium study
Japan |
Mitral valve disease
Cardiovascular surgery |
Others
NO
To assess the efficacy and safety of stentless mitral valve replacement using autologous pericardium for mitral vavle disease that is indicated for surgical treatment but is not suitable for standard mitral valve repair.
Safety,Efficacy
Residual mitral regurgitation two weeks after surgery
Adverse events in 6 months after surgery
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Stentless mitral valve replacement using autologous pericardium
Not applicable |
80 | years-old | > |
Male and Female
1.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.
(4) Symptomatic (NYHA functional class III-IV) moderate or severe mitral stenosis when 1) percutaneous mitral balloon valvotomy is contraindicated because of left atrial thrombus despite anticoagulation or because concomitant moderate to severe MR is present, 2) the valve morphology is not favorable for percutaneous mitral balloon valvotomy, or 3) percutaneous mitral balloon valvotomy has failed.
2. Advamced mitral valve disease that standard mitral valve repair is difficult for and is unlikely to present durable results for.
3. Written informed consent is obtained.
1. Active malignancy
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 valvular operation
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
30
1st name | |
Middle name | |
Last name | Hideyuki Shimizu |
Keio University School of Medicine
Department of Cardiovascular Surgery
35 Shinanomachi, Shinjuku, Tokyo 160-8582, JAPAN
03-5363-3804
hideyuki@keio.jp
1st name | |
Middle name | |
Last name | Hideyuki Shimizu |
Keio University School of Medicine
Department of Cardiovascular Surgery
35 Shinanomachi, Shinjuku, Tokyo 160-8582, JAPAN
03-5363-3804
hideyuki@keio.jp
Keio University School of Medicine
Keio University School of Medicine
Other
NO
2016 | Year | 04 | Month | 01 | Day |
Unpublished
Terminated
2015 | Year | 12 | Month | 18 | Day |
2016 | Year | 03 | Month | 01 | Day |
2016 | Year | 04 | Month | 01 | Day |
2019 | Year | 01 | Month | 01 | Day |
2016 | Year | 03 | Month | 11 | Day |
2019 | Year | 11 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024675
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