UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033433 |
|---|---|
| Receipt number | R000038063 |
| Scientific Title | Transcatheter Closure of Paravalvular Leaks: Evaluation study post Deployment; Prospective Registry |
| Date of disclosure of the study information | 2018/07/18 |
| Last modified on | 2020/02/11 23:24:13 |
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Basic information
Public title
Transcatheter Closure of Paravalvular Leaks: Evaluation study post Deployment; Prospective Registry
Acronym
Transcatheter Closure of Paravalvular Leaks: Evaluation study post Deployment(RESEALED Registry)
Scientific Title
Transcatheter Closure of Paravalvular Leaks: Evaluation study post Deployment; Prospective Registry
Scientific Title:Acronym
Transcatheter Closure of Paravalvular Leaks: Evaluation study post Deployment(RESEALED Registry)
Region
| Japan |
Condition
Condition
Post transcatheter closure of paravalvular leak using Occultech PLD device in RESEAL trial
Classification by specialty
| Medicine in general | Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Paravalvular leak(PVL) is often observed in patients post valve replacement or valve implantation with a reported frequency at 2-17%. Most patients with PVLs are asymptomatic hence requiring no additional therapy, however, small portion of patients can present with recurrent hemolytic anemia and/or heart failure due to paravalvular regurgitation.
Re-do surgery has been proposed as gold standard therapy for these symptomatic PVLs. However, re-do surgery per se are often underwent with high perioperative mortality and morbidity and recurrent PVLs are frequently observed after surgery due to calcification and fragility of the tissue.
Under those circumstances, transcatheter therapy for PVLs has been developed with a first successful report for consecutive four PVL cases in 1992. Recently, ACC/AHA guideline published in 2014 endorses transcatheter therapy for PVLs as class II.
For recent several years, transcatheter therapy for PVL has been performed in sporadic case scenarios as off label therapy in Japan. In 2014, specifically designed device for PVL developed by Occultech (Occultech PLD device) has obtained CE mark approval with favorable initial results.
RESEAL trial (tRancathEter cloSurE of pAravalvular Leaks) which is designed to assess safety and efficacy of Occultech PLD device in five independent institute in Japan is now under recruiting patients. RESEAL trial is built for the purpose of approval of this device in Japan and funded by Japan Medical Association. RESEAL trial will enroll total 30 patients with follow-up periods of six months post deployment. It started at 2016 December , plan to end at 2019 Mar.
In this prospective observational study, RESEALED (tRancathEter cloSurE of pAravalvular Leaks: Evaluation study post Deployment) study, patients enrolled in RESEAL trial will be followed every six months until 24 months post deployment to obtain clinical event and clarify long-term prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis of patients underwent transcatheter closure of paravalvular leaks
: heart failure admissions, cardiovascular interventions( surgery, catheter intervention, device therapy), mortality(all-cause, cardiovascular)
Key secondary outcomes
Improvement of heart failure as assess by PVL grade,BNP,MLWHFQ,6MWD and NYHA class and
improvement of hemolytic anemia as assessed by hemoglobin, reticulocyte, LDH, serum bilirubin.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who were enrolled in RESEAL trial(CTR-096-001, Investigator-led clinical trial to assess safety and efficacy of transcatheter closure of paravalvular leak in high risk symptomatic patients) and completed all required follow-ups
2) Patients who were informed and be abel togive written consent.
Key exclusion criteria
1) Those who are or will be enrolled in other clnical trials.
2) Those who are deemed as inappropriate as subjects of study by institutional investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Arita |
Organization
Kyushu Universitu Hospital
Division name
Heart Center
Zip code
8128582
Address
3-1-1, Maidashi,Higashi-ku, Fukuoka
TEL
092-641-1151
tarita@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Arita |
Organization
Kyushu University Hospital
Division name
Heart Center
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-641-1151
Homepage URL
tarita@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan LIFELINE. Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital IRB
Address
3-1-1, Maidashi, Higashi-ku , Fukuoka
Tel
092-641-1151
tarita@med.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 21 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 21 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
To clarify long-term( up to 2y) prognosis of the patients who underwent transcatheter closure of paravalvular leaks
Management information
Registered date
| 2018 | Year | 07 | Month | 18 | Day |
Last modified on
| 2020 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038063
