UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059696 |
|---|---|
| Receipt number | R000068281 |
| Scientific Title | Efficacy of ablation for combining focal activation and stable high-frequent activity using continuous wavelet transform analysis in persistent Atrial Fibrillation |
| Date of disclosure of the study information | 2025/11/11 |
| Last modified on | 2025/11/08 13:16:45 |
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Basic information
Public title
Efficacy of ablation for combining focal activation and stable high-frequent activity using continuous wavelet transform analysis in persistent Atrial Fibrillation
Acronym
Efficacy of ablation for combining focal activation and stable high-frequent activity using continuous wavelet transform analysis in persistent Atrial Fibrillation
Scientific Title
Efficacy of ablation for combining focal activation and stable high-frequent activity using continuous wavelet transform analysis in persistent Atrial Fibrillation
Scientific Title:Acronym
Efficacy of ablation for combining focal activation and stable high-frequent activity using continuous wavelet transform analysis in persistent Atrial Fibrillation
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with persistent atrial fibrillation undergoing catheter ablation, this study aims to determine whether identifying and ablating atrial fibrillation substrates based on focal trigger activity and frequency analysis can improve clinical outcomes. Patients will be randomly assigned to either an ablation (energy delivery) group or a non-ablation group to compare the efficacy and safety of the two strategies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the absence of atrial fibrillation without the use of antiarrhythmic drugs for one year after the procedure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ablation for combining focal activation and stable high-frequent activity using continuous wavelet transform analysis
Interventions/Control_2
no ablation for combining focal activation and stable high-frequent activity using continuous wavelet transform analysis
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with non-valvular persistent atrial fibrillation who are able to attend regular outpatient visits.
(2) Patients aged 20 years or older at the time of obtaining consent (regardless of sex).
(3) Patients who have provided written informed consent.
Key exclusion criteria
(1) Patients with a confirmed diagnosis of mitral stenosis.
(2) Patients with prosthetic heart valves (mechanical or bioprosthetic).
(3) Patients who have experienced a cardiovascular event (stroke, myocardial infarction, non-infarction cardiac intervention, or heart failure requiring hospitalization) or bleeding requiring hospitalization within one month prior to enrollment.
(4) Patients diagnosed with a life expectancy of less than one year due to any disease.
(5) Patients with left atrial thrombus.
(6) Patients with a left atrial diameter greater than 55 mm.
(7) Patients with a history of catheter ablation.
(8) Patients unable to continue anticoagulant therapy.
(9) Pregnant patients.
(10) Patients with thyroid dysfunction requiring treatment.
(11) Patients with active malignancy.
(12) Patients deemed unsuitable for participation in the study by the attending physician.
Target sample size
147
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kumagai |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Department of Cardiovascular Medicine
Zip code
983-8536
Address
1-15-1, Fukumuro, Miyaginoku Sendai, Miyagi, Japan
TEL
022-259-1221
kkumagai4917@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kumagai |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Department of Cardiovascular Medicine
Zip code
983-8536
Address
1-15-1, Fukumuro, Miyaginoku Sendai, Miyagi, Japan
TEL
022-259-1221
Homepage URL
kkumagai4917@yahoo.co.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Tohoku Medical and Pharmaceutical University
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
Institutional Review Board of Tohoku Medical and Pharmaceutical University Hospital
Address
1-12-1, Fukumuro, Miyaginoku Sendai, Miyagi, Japan
Tel
022-259-1221
research@hosp.tohoku-mpu.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
| 2025 | Year | 11 | Month | 11 | 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
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068281
