UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044934 |
|---|---|
| Receipt number | R000049972 |
| Scientific Title | TranscathetER ModIficatioN of left ATrial appendage by ObliteRation with device |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2024/05/19 00:02:34 |
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Basic information
Public title
TranscathetER ModIficatioN of left ATrial appendage by ObliteRation with device
Acronym
TERMINATOR Registry
Scientific Title
TranscathetER ModIficatioN of left ATrial appendage by ObliteRation with device
Scientific Title:Acronym
TERMINATOR Registry
Region
| Japan |
Condition
Condition
nonvalvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Long term safety and durability of left atrial appendage closure with transcatheter device in Japanese patients with high thromboembolic risk non-valvular atrial fibrillation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death, ischemic stroke, hemorrhagic stroke, disabling stroke, systemic embolism or procedure-related event requiring open heart surgery or significant intravascular intervention within 45 days, 6 months, 1-year, 2-year, 3-year, 4-year, and 5-year.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with non-valvular atrial fibrillation who was attempted to had transcatheter left atrial appendage closure device
Key exclusion criteria
1. Patients who do not agree to this registry
2. Patients under 20 years old
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Hara |
Organization
Toho University Ohashi Medical Center
Division name
Division of Cardiovascular Medicine
Zip code
153-8515
Address
2-22-36 Ohashi, Meguro-ku, Tokyo, Japan
TEL
03-3468-1251
harahide@oha.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidehiko |
| Middle name | |
| Last name | Hara |
Organization
Toho University Ohashi Medical Center
Division name
Division of Cardiovascular Medicine
Zip code
153-8515
Address
2-22-36 Ohashi, Meguro-ku, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
harahide@oha.toho-u.ac.jp
Sponsor or person
Institute
Structure Club Japan
Institute
Department
Personal name
Funding Source
Organization
Structure Club Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Ohashi Medical Center
Address
2-22-36 Ohashi, Meguro-ku, Tokyo, Japan
Tel
03-3468-1251
harahide@oha.toho-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
| 2021 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.journal-of-cardiology.com/article/S0914-5087(23)00240-X/fulltext
Number of participants that the trial has enrolled
Results
The preliminary results demonstrated 729 patients were enrolled. Average age was 74.9. Paroxysmal AF was 37.9 % with average CHADS2 3.2, CHA2DS2-VASc 4.7, and HAS-BLED score of 3.4. WATCHMAN implantation was successful in 99.0 %. All-cause deaths were 3.2 %, and 1.2 % cardiovascular or unexplained deaths occurred. Stroke occurred in 2.2 %, and the composite endpoint were 3.4 %. Major bleeding was seen in 3.7 %, and there was 8.6 % of all bleeding events in total.
Results date posted
| 2024 | Year | 05 | Month | 19 | Day |
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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
recruting
Management information
Registered date
| 2021 | Year | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049972
