UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057298 |
|---|---|
| Receipt number | R000065498 |
| Scientific Title | A Prospective Study of the Efficacy and Safety of Additional Pulsed Field Ablation for Atrial Fibrillation |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/10/10 12:16:10 |
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Basic information
Public title
A Prospective Study of the Efficacy and Safety of Additional Pulsed Field Ablation for Atrial Fibrillation
Acronym
A Prospective Study of the Efficacy and Safety of Additional Pulsed Field Ablation for Atrial Fibrillation
Scientific Title
A Prospective Study of the Efficacy and Safety of Additional Pulsed Field Ablation for Atrial Fibrillation
Scientific Title:Acronym
A Prospective Study of the Efficacy and Safety of Additional Pulsed Field Ablation for Atrial Fibrillation
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of additional applications with pulsed field ablation in patients with atrial fibrillation in the acute and chronic phases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute phase effects of additional applications with pulsed field ablation (isolation and block line success rate, with or without dormant conduction with ATP administration)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
During atrial fibrillation ablation, additional application with pulsed-field ablation is performed if atrial tachycardia/flutter, non-pulmonary venous origin, or arrhythmia substrate is suspected in the right or left atrium other than the pulmonary vein.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All of the following must be met
1) Patients undergoing ablation for atrial fibrillation (of any duration).
2) Female/male patients who are at least 18 years old and less than 90 years old at the time of consent/enrollment.
Key exclusion criteria
Patients should be excluded if any of the following apply
1) Patients with contraindications to anticoagulation.
2) Patients with evidence of thrombus in the left atrium.
3) Other patients who are judged by the principal investigator or co-investigators to be inappropriate for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shushi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Kyoto University Hospital
Division name
Department of Clinical Laboratory
Zip code
606-8507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757514255
s_nishiwaki@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shushi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Kyoto University Hospital
Division name
Department of Clinical Laboratory
Zip code
606-8507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757514255
Homepage URL
s_nishiwaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
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
| 2025 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 03 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065498
