UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045438 |
|---|---|
| Receipt number | R000051877 |
| Scientific Title | CARTO FINDER mapping comparison study of spontaneous atrial fibrillation and induced atrial fibrillation for persistent atrial fibrillation |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2021/12/28 16:24:26 |
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Basic information
Public title
CARTO FINDER mapping comparison study of spontaneous atrial fibrillation and induced atrial fibrillation for persistent atrial fibrillation
Acronym
CARTO FINDER mapping comparison study of spontaneous atrial fibrillation and induced atrial fibrillation for persistent atrial fibrillation
Scientific Title
CARTO FINDER mapping comparison study of spontaneous atrial fibrillation and induced atrial fibrillation for persistent atrial fibrillation
Scientific Title:Acronym
CARTO FINDER mapping comparison study of spontaneous atrial fibrillation and induced atrial fibrillation for persistent atrial fibrillation
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and verify the CARTO FINDER mapping of spontaneous atrial fibrillation and induced atrial fibrillation in patients with persistent atrial fibrillation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of local atrial fibrillation origins identified by a new 3D mapping algorithm
Key secondary outcomes
Comparison of local atrial fibrillation origins identified by a novel 3D mapping algorithm at the time of recurrence
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who have given written consent to this study
2) Patients aged 18 to 85
3) Patients with persistent atrial fibrillation with a duration of 1 week or more and who desire drug resistance or catheter ablation
Key exclusion criteria
1) Patients who cannot undergo catheter ablation due to anticoagulant therapy or intracardiac thrombosis
2) Patients who are unable to return to sinus rhythm Patients with a history of ablation for atrial fibrillation or atypical atrial flutter.
3) Patients after the Maze procedure.
4) Patients undergoing implantable cardiac device (pacemaker, ICD) treatment.
5) Patients who have taken amiodarone within the past year.
6) Untreated hyperthyroidism or hypothyroidism.
7) Patients with end-stage renal disease (patients with eGFR less than 15 or requiring dialysis therapy).
8) Other patients who the doctor judged not to be indicated for this study (patients who are anatomically considered to be difficult to use CARTO FINDER)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Morio |
| Middle name | |
| Last name | Ono |
Organization
Showa University Northern Yokohama Hospital
Division name
Cardiology
Zip code
224-8503
Address
35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
TEL
(+81)45-949-7000
morio.ono@gmail.com
Public contact
Name of contact person
| 1st name | Morio |
| Middle name | |
| Last name | Ono |
Organization
Showa University Northern Yokohama Hospital
Division name
Cardiology
Zip code
224-8503
Address
35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
TEL
(+81)45-949-7000
Homepage URL
morio.ono@gmail.com
Sponsor or person
Institute
Department of Cardiology University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Department of Cardiology University Northern Yokohama Hospital
Address
35-1,chigasakichuuou, yokohamashitudukiku,kanagawa
Tel
(+81)45-949-7000
morio.ono@gmail.com
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
昭和大学横浜市北部病院（神奈川県）
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 | 09 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 10 | 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 | 09 | Day |
Last modified on
| 2021 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051877
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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