Percutaneous transvenous aortic valvuloplasty with a new method

Percutaneous transvenous aortic valvuloplasty with a new method - Percutaneous transvenous aortic valvuloplasty with a new method

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010629

Enrollment

Registered

2013-05-01

Start date

2013-04-23

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

Aortic valve stenosis

Interventions

Inoue balloon catheter for aortic valve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are judged conventional surgery to replace the aortic valve is associated with high risk. 2. Severe aortic valve stenosis with the mean pressure gradient more than 40 mmHg, velocity more than 4.0 m/sec, or aortic valve area less than 1.0 cm2 ( or effective orifice area index less than 0.6cm2/m2). 3. Heart failure symptoms with the NYHA classification greater than class II ( this shall not apply, patient have sudden death risk). 4.The patient agree to this trial with a written informed consent approved by the institutional review board. 5. The patient agree to participate in all follow-up examination after the procedure.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Technical success, Perioperative mortality, Incidence of complication	—

Secondary

Measure	Time frame
Event free survival of total death, Aortic valve stenosis related death, Restenosis rate, Second intervention and surgical conversion	—

Countries

Japan

Contacts

Public ContactNaritatsu Saito

Graduate School of Medicine, Kyoto University Department of Cardiovascular Medicine

naritatu@kuhp.kyoto-u.ac.jp075-751-4254

Outcome results

None listed

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