UMIN-CTR Clinical Trial

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
Email	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
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	Kyushu University Hospital IRB
Address	3-1-1, Maidashi, Higashi-ku , Fukuoka
Tel	092-641-1151
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038063