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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033433
Receipt No. 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 2018/07/18

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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
Middle name
Last name Takeshi Arita
Organization Kyushu Universitu Hospital
Division name Heart Center
Zip code
Address 3-1-1, Maidashi,Higashi-ku, Fukuoka
TEL 092-641-1151
Email tarita@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Arita
Organization Kyushu University Hospital
Division name Heart Center
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-641-1151
Homepage URL
Email tarita@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 07 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2018 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038063

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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