UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041752 |
|---|---|
| Receipt number | R000047253 |
| Scientific Title | Impact of additional ablation for localized atrial fibrillation sources using a novel three-dimensional mapping system algorithm on atrial tachyarrhythmia recurrence in patients with persistent atrial fibrillation: a prospective randomized study |
| Date of disclosure of the study information | 2020/09/16 |
| Last modified on | 2023/01/21 23:16:31 |
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Basic information
Public title
Impact of ablation for localized atrial fibrillation sources in patients with longstanding atrial fibrillation: a prospective randomized study
Acronym
Evaluation of ablation for localized atrial fibrillation sources
Scientific Title
Impact of additional ablation for localized atrial fibrillation sources using a novel three-dimensional mapping system algorithm on atrial tachyarrhythmia recurrence in patients with persistent atrial fibrillation: a prospective randomized study
Scientific Title:Acronym
Effect of ablation for localized atrial fibrillation sources identified by a novel three-dimensional mapping algorithm
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether additional ablation to localized atrial fibrillation sources using a novel algorithm of three-dimensional mapping system (CARTOFINDER, Biosense Webster) plus conventional pulmonary vein isolation and ablation of non-pulmonary vein foci reduces atrial tachyarrhythmia recurrence in patients with persistent atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Survival free rate from atrial tachyarrhythmia recurrence during 12 months follow-up after the index ablation
Key secondary outcomes
1. Procedural detail data including procedure time and complications
2. Relationship between left atrial low voltage area and atrial tachyarrhythmia recurrence rate after additional ablation to localized atrial fibrillation sources plus conventional pulmonary vein isolation and ablation of non-pulmonary vein foci
3. Change of left atrial function before and six months after the index ablation between two groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with persistent atrial fibrillation undergoing pulmonary vein isolation and non-pulmonary vein foci ablation
Interventions/Control_2
Patients with persistent atrial fibrillation undergoing ablation for the localized atrial fibrillation sources identified by CARTOFINDER in addition to pulmonary vein isolation and non-pulmonary vein foci ablation
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who have agreed to this study in the document
2) Patients aged 18 to 80
3) Patients with persistent atrial fibrillation with a duration of 1 week or more with drug resistance or wish for catheter ablation
4) Patients with a left atrium diameter of 55 mm or less
5) Patients with a left ventricular ejection fraction of over 45%
Key exclusion criteria
1) Patients with contraindications to anticoagulant therapy or unable to undergo catheter ablation due to cardiac thrombosis
2) Patients who have previously undergone catheter ablation for atrial fibrillation
3) Patients with a postprecedural follow-up period of less than six months
4) Patients with moderate or severe mitral or aortic valve valvular disease (regurgitation/stenosis)
5) Patients with hypertrophic cardiomyopathy
6) Patients with a history of myocardial infarction
7) Patients after transplantation of cardiac implantable electronic device
8) Patients for whom this study is not indicated because of other reasons (e.g., patients considered to be anatomically difficult to use CARTOFINDER)
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Nagase |
Organization
Sakakibara heart institute
Division name
Cardiology
Zip code
183-0003
Address
3-16-1 Asahi-cho, Fuchu-shi, Tokyo
TEL
(+81)42-314-3111
tnagase@shi.heart.or.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Nagase |
Organization
Sakakibara heart institute
Division name
Cardiology
Zip code
183-0003
Address
3-16-1 Asahi-cho, Fuchu-shi, Tokyo
TEL
(+81)42-314-3111
Homepage URL
tnagase@shi.heart.or.jp
Sponsor or person
Institute
Department of Cardiology, Sakakibara heart institute
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
1. Higashiyamato hospital
2. IMS Fujimi general hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Sakakibara heart institute
Address
3-16-1 Asahi-cho, Fuchu-shi, Tokyo 183-0003
Tel
(+81)42-314-3111
sohta@mail.heart.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
１．公益財団法人 榊原記念財団 榊原記念病院（東京都） Sakakibara heart institute
２．社会医療法人財団大和会 東大和病院（東京都） Higashiyamato hospital
３．イムス富士見総合病院（埼玉県） IMS Fujimi general hospital
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Due to the restrictions on catheter ablation at facilities following repeated epidemics of new coronavirus infections and the fact that CARTOFINDER mapping itself requires about an additional hour, it takes time to register cases. Furthermore, it was confirmed that it takes time to accumulate cases by dividing the cases into two groups in a randomized prospective study. On top of that, considering the early return of the study results, it is considered better that the study design will be changed to a retrospective observational study comparing groups propesity score matching. This prospective randomized study was terminated because of those reasons.
Management information
Registered date
| 2020 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047253
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/07/23 | 2022.3.17 研究実施計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/03/13 | 2022.3 UMIN 症例データ仕様書.xls |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/03/13 | UMIN_CARTOFINDER研究データ_2022.3 .xls |
Single case data URL
Value
https://center6.umin.ac.jp/ice/47253
