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

Not Applicable

Recruiting

• Conditions: Severe aortic stenosis

• Registration Number: JPRN-UMIN000047359
• Lead Sponsor: Shonan Kamakura General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-20
• Last Update Posted: 17 October 2023
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of next-day discharge after TAVR

Secondary Outcome Measures

Name	Time	Method
1) Time of mobilization from TAVR procedure 2) Incidence of Delirium 3) Clinical/Subclinical stroke evaluated by MRI one day after procedure Safety endpoint: 1) TAVR procedural success 2) Complication based on Valve academic research consortium-3 criteria 3) major vascular and/or bleeding complications based on Valve academic research consortium-3 criteria 4) 30-sy mortality 5) Clinical/Subclinical stroke evaluated by MRI one day after procedure 6) Other adverse events