UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059827 |
|---|---|
| Receipt number | R000067785 |
| Scientific Title | Evaluation of the Efficacy of Rotor-Guided Pulsed Field Ablation for Extended Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/19 16:47:06 |
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Basic information
Public title
Evaluation of the Efficacy of Rotor-Guided Pulsed Field Ablation for Extended Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation
Acronym
Rotor guided PFA EPVI trial
Scientific Title
Evaluation of the Efficacy of Rotor-Guided Pulsed Field Ablation for Extended Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation
Scientific Title:Acronym
Rotor guided PFA EPVI trial
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether ExTRa mapping-guided extended pulmonary vein isolation during catheter ablation for persistent atrial fibrillation improves the non-recurrence rate of atrial arrhythmias.
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
Safety
Procedure time
Association between data obtained from ExTRa Mapping and recurrence rate
AF/AT burden at 3 and 12months (Holter ECG or Long-term Holter ECG)
Recurrence of atrial arrhythmias after additional ablation performed following recurrence after 90 days post-procedure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ExTRa Mapping of the left atrium and pulmonary vein (PV) antrum will be performed prior to pulmonary vein isolation (PVI). Areas with a non-passive ratio >=25% by Advisor HD-Grid will be marked on the NAVX system. In addition to standard PVI, pulsed field ablation (PFA) will be applied to modify the rotor areas around the left atrial PV antrum.
Interventions/Control_2
No additional ablation after pulmonary veins isolation
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
First time ablation procedure for persistent atrial fibrillation
Patients from who we get written informed consent
Key exclusion criteria
Age >= 85 years
Estimated glomerular filtration rate (eGFR) < 30 mL/min
Left atrial diameter >= 50 mm on transthoracic echocardiography
Left ventricular ejection fraction (LVEF) <= 35%
chronic heart failure of NYHA class IV
Patients with implanted pacemakers or implantable cardioverter-defibrillators (ICDs)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Kita-Harima Medical Center
Division name
Cardiology
Zip code
675-1392
Address
926-250 Ichiba-cho, Ono, 6751392, Japan.
TEL
0794-88-8800
ayoshida@kitahari-mc.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Suzuki |
Organization
Kita-Harima Medical Center
Division name
Cardiology
Zip code
674-0063
Address
926-250 Ichiba-cho, Ono, 6751392, Japan.
TEL
0794-88-8800
Homepage URL
yuyasuzuki1217@gmail.com
Sponsor or person
Institute
Kita-Harima Medical Center
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
KIta-Harima Medical Center, Ethics Committee
Address
926-250 Ichiba-cho, Ono, 6751392, Japan.
Tel
0794888800
kazuhiro_toso@kitahari-mc.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 | 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
| 2025 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 10 | 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 | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067785
