Transcatheter Closure of Prosthetic Paravalvular Leaks

Phase 2

Completed

• Conditions: Symptomatic Prosthetic Paravalvular leaks in high risk patients

• Registration Number: JPRN-jRCT1090220267
• Lead Sponsor: Kyushu University Hospital, Academic Research Organization, CTR096 Clinical Trial Office

Brief Summary

As primary endpoint, procedural success rate were 65.5% (n=29, p=0.5617) according to the echo core lab analysis and 89.7% (n=29, p=0.0026) according to the institutional physician assessment. Secondary endpoint analysis revealed significant improvement of mitral PVL grade and heart failure or QOL measures without persistent hemolytic anemia. As another primary endpoint, there was neither device nor procedure-related death at 30day post procedure or in hospital. In conclusion, this study successfully showed significant safety and efficacy of the transcatheter closure of PVL leaks using the specifically-designed device.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-05
• Study Completion: 2019-03-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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. Hb<10g/dl and LDH>600IU/l and haptoglobin<10mg/dl. or requirement of MAP transfusion during recent 90days to achieve Hb level >10g/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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: Procedural success rate of device deployment<br>Primary Safety Endpoint: 30 day post-procedural and in-hospital mortality rat

Secondary Outcome Measures

Name	Time	Method
*Any adverse event rate during study period<br>*Improvement of hemolytic anemia<br>*Improvement of PVL<br>*Improvement of heart failure<br>*Improvement of QO