UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045447 |
|---|---|
| Receipt number | R000051888 |
| Scientific Title | Retrospective study about the prognosis in patients with non-valvular atrial fibrillation who underwent a percutaneous left atrial appendage closure. |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2023/09/13 22:24:24 |
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Basic information
Public title
Retrospective study about the prognosis in patients with non-valvular atrial fibrillation who underwent a percutaneous left atrial appendage closure.
Acronym
Retrospective study about left atrial appendage closure device
Scientific Title
Retrospective study about the prognosis in patients with non-valvular atrial fibrillation who underwent a percutaneous left atrial appendage closure.
Scientific Title:Acronym
Retrospective study about left atrial appendage closure device
Region
| Japan |
Condition
Condition
Nonvalvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with nonvalvular atrial fibrillation who underwent percutaneous left atrial appendage closure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause death
Key secondary outcomes
cardiovascular death, ischemic stroke, major bleeding event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
percutaneous left atrial appendage clusore
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with nonvalvular atrial fibrillation who have a high risk of stroke and systemic embolism, based on the CHADS2 or CHA2DS2-VASc scores and a high risk of bleeding with at least one following condition.
- Patients with a HAS-BLED score of 3 or higher
- Patients with a history of trauma associated with a fall that required treatment for multiple injuries
- Patients with a history of diffuse cerebral amyloid angiopathy
- Patients who require the concomitant use of two or more antiplatelet agents for an extended period of time (more than 1 year)
- Patients with a history of major bleeding that meets the BARC type 3 criteria
Key exclusion criteria
1. patients requiring long-term use of oral anticoagulants for reasons other than non-valvular atrial fibrillation (e.g., patients with implanted mechanical prosthetic valves, patients with hypercoagulable states, or patients with recurrent DVT)
2. patients with evidence of intracardiac (especially intra-atrial) thrombus.
3. patients with atrial septal defect or foramen ovale repair (surgery, device implantation, etc.), or patients with atrial septal defect or foramen ovale repair (surgery, device implantation, etc.).
Patients with a history of atrial septal defect or atrial septal suture closure.
4. patients with anatomical structures of the left ventricular ear that are not amenable to closure devices.
5. patients with contraindications to left ventricular closure (transesophageal echocardiography (TEE)) or patients with contraindications to left ventricular closure (e.g., difficulty in inserting transesophageal echocardiography (TEE) probe or catheter required for the procedure).
6. patients with contraindications to anticoagulation, aspirin, or thienopyridine.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Fukunaga |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
802-8555
Address
3-2-1, Asano kokurakita, Kitakyushu Japan
TEL
0935112000
masato_f0728@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Fukunaga |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
802-8555
Address
3-2-1, Asano kokurakita, Kitakyushu Japan
TEL
093-511-2000
Homepage URL
masato_f0728@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiology, Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review board of Kokura Memorial Hospital
Address
3-2-1, Asano kokurakita, Kitakyushu Japan
Tel
093-511-2000
rinsyo@kokurakinen.or.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
小倉記念病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2031 | Year | 09 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051888
