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Clinical Trials/JPRN-UMIN000047359
JPRN-UMIN000047359
Recruiting
未知

Efficacy and safety of primary percutaneous trans-axillary artery transcatheter aortic valve replacement for severe aortic stenosis - Primary trans-axillary artery access TAVR for AS

Shonan Kamakura General Hospital0 sites25 target enrollmentMay 20, 2022

Overview

Phase
未知
Intervention
Not specified
Conditions
Severe aortic stenosis
Sponsor
Shonan Kamakura General Hospital
Enrollment
25
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 20, 2022
End Date
October 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\) contraindication for bioprosthesis implantation 2\) Contraindication for following medicine aspirine, ticlopidine, heparine or contrast medium 3\) active endocarditis or sepsis 4\) Left ventricular thrombus 5\) decompensated heart failure with NYHA4 symptom 6\) Cardiogenic shock with hemodynamic mechanical support 7\) Post coronary artery graft bypass using ipsilateral internal mammary artery 8\) Post pacemaker implantation at ipsilateral axillary vein 9\) coronary artery disease with Indication for coronary artery bypass graft surgery 10\) Indication for surgical valvular treatment 11\) Blood disease: WBC\<1000mm3,Plt\<50000cellc/mm3 12\) Severe dementia 13\) Life\-expectancy\<1year due to other than heart disease 14\) pregnancy or breast\-feed 15\) access artery diameter\<5mm by CT or echo 16\) severe calcification or tortuosity of access 17\) inhibitive anatomy for trans femoral access 18\) Aorto\-subclavian angle\>90degree 19\) Subclavian artery originated from distal aortic arch

Outcomes

Primary Outcomes

Not specified

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