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Clinical Trials/JPRN-UMIN000018398
JPRN-UMIN000018398
Completed
未知

Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve - Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve

Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine0 sites5 target enrollmentAugust 1, 2015

Overview

Phase
未知
Intervention
Not specified
Conditions
Failing bioprosthetic Valve
Sponsor
Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine
Enrollment
5
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2015
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\. history of coronary infarction within previous 1 month 2\. PCI or PTA within previous 1 month 3\-1\. WBC\<1000 3\-2\. Plt\<50000 3\-3\. history of coagulation disorder 3\-4\. hyper coagulability state 4\. untreated coronary artery disease requiring revascularization 5\. cardiac shock or state requiring mechanical support 6\. emergent operation 7\. EF \<20% 8\. CVA or TIA within previous 1 month 9\. active gastrointestinal bleeding 10\. 1 Aspirin, 2 ticlopidine hydrochloride, 3 heparin, 4 contrast agents, 5 Nitinol was contraindication. 11\. active endocarditis 12\. refusal of blood transfusion 13\. life expectancy less than 12 months due to associated non\-cardiac comorbid condition 14\. severe dementia 15\. participation of other clinical trial 16\. carotid or vertebral artery stenosis with symptoms 17\. Heart team is not agree regarding medical, social, or psychological state 18\. at least 1 cardiovascular surgeon and 1 cardiologist are not agree regarding anatomical findings. 19\. HCM 20\. presence of vegetation 21\. HOCM 22\. potential of coronary obstruction

Outcomes

Primary Outcomes

Not specified

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