Safety and Efficacy of transcatheter closure of paravalvular leaks

Not Applicable

• Conditions: symptomatic paravalvular leak after valve replacement surgery

• Registration Number: JPRN-UMIN000019656
• Lead Sponsor: Kyushu University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who, at the start of screening, meet any of the following criteria are not eligible for the study: 1) Uncorrectable coagulopathy or bleeding tendency. 2) Contraindication for emergent transfusion/antiplatelet 3) Anatomically difficult for femoral puncture 4) Severe liver dysfunction 5) Severe uncontrollable systemic or local infection 6) Known allergy or contraindication for contrast 7) Known allergy for nickel/titan/stenless steel/platinum/iridium 8) Past history of severe drug allergy 9) Patients with organic lesion with hemorrhagic risk including hemorrhagic stroke within past six months 10) Patients with possible bleeding disorder(internal malignancy, diverticulitis, colitis, subacute bacterial endocarditis, severe hypertension, uncontrolled diabetes etc) 11) Patients enrolled to other clinical study with intervention or clinical trial by medicine or device within past six months 12) Intracardiac thrombus formation 13) Patients deemed as inappropriate for participating in the study by principal investigator or subinvestigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified