symptomatic paravalvular leak after valve replacement surgery
Conditions
Interventions
To deploy occlusion device( Amplatzer Vascular Plug II(IV) or Occultech PLD device) according to the size and shape of the PVLs. Anatomy and location of the PVL should be carefully reviewed to determi
Sponsors
Kyushu University Hospital
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 3) Life expectancy more than 1 year 4) Suitable anatomy for transcatheter closure of the PVLs 5) No coagulopathy disease 6) Presence of either or both for symptomatic(NYHA class 2 or more)heart failure due to paravalvular regurgitation post valve replacement of the mitral /aortic valve or refractory hemolytic anemia due to PVLs requiring frequent episodes of transfusion(Hb<10g/dl and LDH>600IU/l and haptoglobin<10mg/dl. or requirement of MAP transfusion or EPO administration during recent 90days to achieve Hb level >10g/dl). 7) Patients deemed as high risk or inoperable for re-do surgery 8) Patients is informed well and can understand the study protocol by the attending physician. 9) 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate of deployment of the closing device in the acute settings. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe Adverse events observed during the whole study period. Improvement of hemolytic anemia (LDH, Hb, Ht, Haptoglobin, TBil, urine bil) Improvement of paravalvular regurgitation (by Echo), LV function, LV size, BNP level Improvement of NYHA class Improvement of QOL score as determined by MLHFQ | — |
Countries
Japan
Contacts
Public ContactTakeshi Arita
Kyushu University Hospital Heart Center
Outcome results
None listed