Percutaneous transvenous aortic valvuloplasty with a new method

Not Applicable

Recruiting

• Conditions: Aortic valve stenosis

• Registration Number: JPRN-UMIN000010629
• Lead Sponsor: Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-01
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

1. Acute myocardial infarction within 1 month. 2. Unicuspid aortic valve. 3. Severe aortic valve regurgitation. 4. Prior valve surgery. 5. Need of the emergency surgery by some kind of reasons why an aortic stenosis does not have relations. 6.Obstructive or nonobstructive cardiomyopathy. 7. Severe LV dysfunction (LVEF<20%). 8. Active gastrointestinal ulcer or history of upper gastrointestinal bleeding within 3 months. 9. Allergy to heparin. 10. CVA or TIA within 6 month. 11. Life expectancy less than 12 months due to non-cardiac disease. 12. Involvement in another clinical trial. 13. Allergy to latex. 14. Making the safe insertion of sheath introducer impossible by thrombosis from the common iliac vein through the femoral vein. 15. Cardiologist and cardiovascular surgeon decision not to register to this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success, Perioperative mortality, Incidence of complication

Secondary Outcome Measures

Name	Time	Method
Event free survival of total death, Aortic valve stenosis related death, Restenosis rate, Second intervention and surgical conversion