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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047359

Enrollment

Registered

2022-05-20

Start date

2022-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe aortic stenosis

Interventions

Percutaneous trans-axillary artery TAVR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosis of severe aortic stenosis by transthoracic echocarrdiogram: (AVA<1.0cm2 or AVAi<0.6cm2/m2 )and (peak AV>4.0m/s or mean aortic gradient >40mmHg) 2) Age >74 at the time of TAVR 3) NYHA >1 symptom 4) LVEF >50% 5) Suitable femoral and axillary artery access for both transfemoral and transaxillary arteryTAVR by MDCT 6) Written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Achievement of next-day discharge after TAVR	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactNoriaki Moriyama

Shonan Kamakura General Hospital Cardiology

e2718nm@gmail.com0467461717

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026