Percutaneous transvenous aortic valvuloplasty with a new method

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2013
INTERVENTION: Inoue balloon catheter for aortic valve CONDITION: Aortic valve stenosis PRIMARY OUTCOME: Technical success, Perioperative mortality, Incidence of complication SECONDARY OUTCOME: Event free survival of total death, Aortic valve stenosis related death, Restenosis rate, Second intervention and surgical conversion 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.
Epistemonikos ID: 4078a98e189362790991667ea8e19200f8a796ee
First added on: Aug 22, 2024