Symptomatic Prosthetic Paravalvular leaks in high risk patients
Conditions
Interventions
Intervention type:DEVICE,PROCEDURE
Name of intervention:Transcatheter closure of paravalvular leak
Dose form / Japanese Medical Device Nomenclature:DEVICE
Occlutech PLD
Route of administration / Site
Sponsors
Kyushu University Hospital, Academic Research Organization, CTR096 Clinical Trial Office
Kyushu University Hospital, National Cerebral and Cardiovascular Center, Iwate Medical School, Ryukyu University,Toho University Ohashi Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all the following criteria at the screening period are eligible for the study: 1) More than 20 years of age 2) Presence of paravalvular leak after valve replacement (including transcatheter valve) 3) Life expectancy more than 1 year 4) Suitable anatomy for transcatheter closure of the PVLs 5) Presence of either or both 1. symptomatic(NYHA class 2 or more)heart failure due to paravalvular regurgitation post valve replacement of the mitral /aortic valve 2.refractory hemolytic anemia due to PVLs with symptoms or requiring frequent episodes of transfusion(i.e. Hb600IU/l and haptoglobin10g/dl). 6) Patients deemed as high risk or inoperable for re-do surgery 7) Patients is informed well and can understand the study protocol by the attending physician. 8) Patients give written informed consent voluntarily to attend the study
Exclusion criteria
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) Difficult anatomy for femoral puncture 4) Severe uncontrollable systemic or local infection 5) Unable to be anesthetized due to known drug allergy 6) Known serious allergy or contraindication for contrast 7) Known allergy for nickel/titan/stenless steel/platinum/iridium 8) Past history of severe allergy to the drugs planned to be given 9) Patients with clinical relevant organic lesion with hemorrhagic risk 10) Patients in pregnancy, at risk for pregnancy or those who plan pregnancy during the study period 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) Profound difficulties or contraindication for performing transesophageal echocardiography 14) Patients deemed as inappropriate for participating in the study by principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint: Procedural success rate of device deployment Primary Safety Endpoint: 30 day post-procedural and in-hospital mortality rat | — |
Secondary
| Measure | Time frame |
|---|---|
| *Any adverse event rate during study period *Improvement of hemolytic anemia *Improvement of PVL *Improvement of heart failure *Improvement of QOL | — |
Countries
Japan
Contacts
Public ContactTakeshi Arita MD, PhD
Kyushu University Hospital
Outcome results
None listed