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Clinical Trials/JPRN-UMIN000006880
JPRN-UMIN000006880
Recruiting
N/A

Trans-catheter aortic valve implantation - Trans-catheter aortic valve implantation

Osaka University Graduate School of medicine Department of Cardiovascular Surgery, Department of Cardiology0 sites53 target enrollmentDecember 12, 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Severe aortic valve stenosis
Sponsor
Osaka University Graduate School of medicine Department of Cardiovascular Surgery, Department of Cardiology
Enrollment
53
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 12, 2011
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Osaka University Graduate School of medicine Department of Cardiovascular Surgery, Department of Cardiology

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\. acute myocardial infarction within 1 month 2\. unicuspid, bicuspid aortic valve, or aortic valve stenosis without calcification 3\. severe aortic valve regurgitation 4\. cardiac intervention within 30 days (or intervention with drug eluting stent within 6 months) 5\.prior valve surgery with artifical valve, ring. or severe mitral valve regurgitation greater than 3\+/4\. 6\.leukopenia, acute anemia,thrombocytopenic purpura. or past history of coagulation disorder. 7\.coronary artery disease with significant stenosis requiring intervention. 8\. unstable circulation requiring mechanical support 9\.emergency procedure 10\.obstructive cardiomyopathy 11\. severe LV dysfunction (LVEF\<20%) 12\. cardiac tumor, thrombus, vegetation in UCG 13\. active gastrointestinal bleeding or history of upper gastrointestinal bleeding within 3 month 14\. allergy of aspirin, heparin, ticropigin, contrast medium. 15\. aortic valve annulus less than 16mm or larger than 24mm 16\. CVA or TIA within 6 months 17\. life expectancy less than 12 months by non\-cardiac disease 18\. involvement to another clinical trial 19\. inappropriate another factors (judged by cardiologist or cardiovascular surgeon)

Outcomes

Primary Outcomes

Not specified

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