UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052490 |
|---|---|
| Receipt number | R000059743 |
| Scientific Title | Extra ablation beyond puLmonary vein Isolation Nurtures Elimination of atrial fibrillation, or not? (Ext-LINE) Study |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/10/13 16:38:24 |
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Basic information
Public title
Extra ablation beyond puLmonary vein IsolationNurtures Elimination of atrial fibrillation, or not? (Ext-LINE) Study
Acronym
Ext-LINE Study
Scientific Title
Extra ablation beyond puLmonary vein Isolation Nurtures Elimination of atrial fibrillation, or not? (Ext-LINE) Study
Scientific Title:Acronym
Ext-LINE Study
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluated the utility of additional ExTRa mapping-guided ablation and linear ablation beyond pulmonary vein isolation for persistent atria l fibrillation in reducing recurrent tachyarrhythmias after procedure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Atrial arrhythmia recurrence beyond 90 days after catheter ablation for atrial fibrillation
Key secondary outcomes
Cardiac function after procedure
Procedure detail (procedure time, ablation number, ablation region)
Atrial fibrillation termination rate during procedure
Adverse events
Atrial arrhythmia recurrence beyond 90 days after repeat procedures
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Atrial sites of high %NP (Mean %NP >35% and low voltage area <0.5mV) were ablated and ExTRa mapping-guided anatomical linear ablation was added after pulmonary vein isolation, and electrical cardiversion was performed when sinus restoration was not obtained in 15 minutes after injection of Nifekalant 0.3mg/kg
Interventions/Control_2
Interventions/Control_3
pulmonary vein isolation
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
First time ablation procedure for persistent atri al fibrillation
Patients who can be followed for at least 1-year after procedure Patients from who we get written informed consent
Key exclusion criteria
Patients with AF termination only by pulmonary vein isolation
Patients who received ablation procedure or MAZE procedure for for atrial fi brillation before enrollment
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Shizuta |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4254
shizuta@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuma |
| Middle name | |
| Last name | Kawaji |
Organization
Mitsubishi Kyoto Hospital
Division name
Department of Cardiology
Zip code
615-8087
Address
1 Katsura Gosho-cho, Nishikyo-ku, Kyoto
TEL
075-381-2111
Homepage URL
kawaji@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Operation Cost Grant
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mitsubishi Kyoto Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School of Medicine and Faculty of Medicine, Ethics Committee
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Kyoto, Kyoto, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2023 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059743
