UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057347 |
|---|---|
| Receipt number | R000065544 |
| Scientific Title | ADditional non-pV AblatioN for ComplicatED atrial fibrillation with Pulse Field Ablation Study |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/19 18:47:56 |
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Basic information
Public title
ADditional non-pV AblatioN for ComplicatED atrial fibrillation with Pulse Field Ablation Study
Acronym
ADVANCED PFA Study
Scientific Title
ADditional non-pV AblatioN for ComplicatED atrial fibrillation with Pulse Field Ablation Study
Scientific Title:Acronym
ADVANCED PFA Study
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study to verify the efficacy of pulmonary vein isolation and additional treatment using pulsed field ablation for refractory atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non-recurrence rate of atrial arrhythmias at 12 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Intraoperative intervention after pulmonary vein isolation with pulsed-field ablation, with additional pulsed-field ablation to non-pulmonary vein origin and substrate
Interventions/Control_2
No additional intraoperative intervention after pulmonary vein isolation with pulsed-field ablation
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 undergoing pulsed field ablation for paroxysmal and persistent AF
2) Patients over the age of 21 and under the age of 90
3) Patients who can be followed up for 1 year at the institution or referring hospital
4) Patients who have given informed consent
Key exclusion criteria
1) Patients who do not tolerate pulsed field ablation
2) Patients younger than 20 years and older than 80 years
3) Patients who have difficulty with 1-year follow-up
4) Patients with NYHA class IV heart failure
5) Left atrial diameter >60mm
6) Patients with very long-term persistent AF with an estimated duration of >10 years
7) Patients who cannot continue appropriate anticoagulation therapy
8) Patients who have had a myocardial infarction within the past 6 months
9) Patients scheduled for open heart surgery
10) Patients with severe valvular disease
11) When the patient's written informed consent cannot be obtained
12) When the attending physician's consent cannot be obtained
13) Other patients deemed inappropriate by the attending physician
Patients diagnosed with a life expectancy of less than 1 year due to malignant disease or other non-cardiac disease
Pregnant patients
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Oooka |
Organization
Kobe City Medical Center General Hospital
Division name
Division of cardiovascular medicine
Zip code
650-0047
Address
2-1-1 Minatojima-minamimachi, Chuou-ku, Kobe
TEL
078-302-4321
junichi_ooka@kcho.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kobori |
Organization
Kobe City Medical Center General Hospital
Division name
Division of cardiovascular medicine
Zip code
650-0047
Address
2-1-1 Minatojima-minamimachi, Chuou-ku, Kobe
TEL
078-302-4321
Homepage URL
kobori@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Kobe City Medical Center General Hospital
Funding Source
Organization
Kobe City Medical Center General Hospital
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
Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima-minamimachi, Chuo-Ku, Kobe
Tel
0783024321
rinken@kcho.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 | 04 | 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 | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | 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 | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065544
