UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060411 |
|---|---|
| Receipt number | R000069111 |
| Scientific Title | Tohoku Observational Study for Atrial Fibrillation Patients with Treatment by Pulse Field ablation Registry Study |
| Date of disclosure of the study information | 2026/01/21 |
| Last modified on | 2026/01/20 15:58:06 |
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Basic information
Public title
Tohoku Observational Study for Atrial Fibrillation Patients with Treatment by Pulse Field ablation Registry Study
Acronym
TOHOKU PFA Study
Scientific Title
Tohoku Observational Study for Atrial Fibrillation Patients with Treatment by Pulse Field ablation Registry Study
Scientific Title:Acronym
Tohoku Observational Study for Atrial Fibrillation Patients with Treatment by Pulse Field ablation Registry Study
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 clarify the clinical usefulness and remaining challenges of pulse field ablation (PFA) catheters for atrial fibrillation by analyzing their effectiveness and safety following ablation procedures in a large-scale, regional multicenter registry across the Tohoku area.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Absence of documented atrial fibrillation, atrial tachycardia, or atrial flutter lasting 30 seconds or longer without antiarrhythmic drug therapy, from 3 months after the procedure until the 12-month follow-up assessment.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with a confirmed diagnosis of non-valvular atrial fibrillation who are able to attend outpatient follow-up visits.
(2) Patients aged 20 years or older at the time of informed 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 valves).
(3) Patients who experienced a cardiovascular event (stroke, myocardial infarction, nonmyocardial infarction cardiovascular intervention, or heart failure requiring hospitalization) or bleeding requiring hospitalization within 1 month prior to enrollment.
(4) Patients with a life expectancy of less than 1 year due to any underlying disease.
(5) Patients with left atrial thrombus.
(6) Patients who are unable to continue oral anticoagulant therapy.
(7) Pregnant patients.
(8) Patients with active malignancy.
(9) Patients who are otherwise deemed inappropriate for study participation by the attending physician.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kumagai |
| Middle name | |
| Last name | Koji |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Department of Cardiovascular Medicine
Zip code
983-8536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-259-1221
kkumagai4917@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kumagai |
| Middle name | |
| Last name | Koji |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Department of Cardiovascular Medicine
Zip code
983-8536
Address
1-15-1 Fukumuro, Miyagino-ku, 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
| 2026 | Year | 01 | Month | 21 | 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 | 10 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-arm, multicenter, prospective observational study and is an investigator-initiated clinical study. No therapeutic intervention will be performed as part of this study, and data will be collected within the scope of routine clinical practice.
Eligible patients will undergo pulse field ablation (PFA) catheter ablation after enrollment. Thereafter, patients will be prospectively followed and evaluated on the day of the procedure and at 3, 6, 9, and 12 months after the procedure.
Management information
Registered date
| 2026 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069111
