UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057894 |
|---|---|
| Receipt number | R000065876 |
| Scientific Title | Multicenter Clinical Study for Comparing Tissue Healing Processes After Atrial Fibrillation Ablation of Pulsed Field Ablation versus Radiofrequency Ablation |
| Date of disclosure of the study information | 2025/05/17 |
| Last modified on | 2026/08/07 18:24:22 |
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Basic information
Public title
Multicenter study comparing tissue healing after pulsed field ablation versus radiofrequency ablation for atrial fibrillation
Acronym
TISSUE HEAL PFA study
Scientific Title
Multicenter Clinical Study for Comparing Tissue Healing Processes After Atrial Fibrillation Ablation of Pulsed Field Ablation versus Radiofrequency Ablation
Scientific Title:Acronym
TISSUE HEAL PFA study
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the differences in tissue healing processes, particularly with respect to autonomic nervous system involvement, between pulsed field ablation (PFA) and conventional radiofrequency ablation (RFA). By clarifying these differences, we seek to enhance understanding of the unique characteristics of PFA and generate novel evidence to inform acute and subacute post-procedural management strategies.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Early recurrence of atrial fibrillation during the 3-month post-ablation blanking period
Key secondary outcomes
[Ablation Parameters]
Elimination rate of vagal responses in five major ganglionated plexi (GP) regions, which demonstrated positive vagal responses to high-frequency stimulation (HFS) prior to ablation, re-evaluated post-ablation.
Presence of vagal responses during ablation.
RFA params: power, impedance, irrigation flow rate, RF delivery time, temperature, contact force (CF), force-time integral (FTI), ablation index (AI), and VisiTag data [percentage of lesions meeting criteria for catheter tip stability (within a predefined range of movement) and minimum CF during a set time].
PFA params: number of PFA applications per pulmonary vein; proportion of applications with positive tissue proximity indication (TPI).
Number and locations of pulmonary vein reconnections.
Total ablation time.
LA dwell time: the time from initial catheter access to the left atrium to its removal after the final ablation lesion.
Procedure time.
Fluoro time.
[Outcomes at 12 Months Post-Ablation]
Clinical AF recurrence beyond the 3-month blanking period.
Stroke, transient ischemic attack (TIA), or systemic embolism.
CV events: stroke/TIA, MI/UA, CV death, sudden cardiac death, or admission due to HF.
Major bleeding (ISTH).
All-cause mortality.
Clinically significant bleeding.
MI or UA.
Admission due to HF or other CV causes.
CV death.
[Changes from Baseline to 12 Months]
Body weight.
Blood pressure and heart rate.
Lab tests: WBC, Hb, CK, CK-MB, Cr, BUN, UA, hs-CRP, INR, APTT, D-dimer, TnT, HbA1c, T-cho, LDL, HDL, TG, NT-proBNP (or BNP).
Symptoms.
QoL (SF-12).
Heart rate variability (HRV).
Use of AADs and anticoagulants.
Echo: LAD, LAV, LAVI, LVEF, LVMI, E/e', valvular disease.
3D CT: LA and EAT volumes (1 mo pre-procedure and 12 mo post).
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age between 18 and 80 years at the time of ablation.
Patients with symptomatic paroxysmal atrial fibrillation refractory to pharmacological therapy (ineffectiveness of at least one class I-IV antiarrhythmic drug).
Patients with non-valvular atrial fibrillation undergoing first-time catheter ablation.
Patients who have received sufficient explanation regarding the study, fully understand its content, and have provided written informed consent of their own free will.
Key exclusion criteria
Presence of left atrial thrombus detected on pre-procedural imaging.
Left ventricular ejection fraction (LVEF) < 40%.
Diagnosis of hypertrophic cardiomyopathy or severe valvular heart disease.
Receiving maintenance hemodialysis.
Any other condition deemed inappropriate for study participation by the principal investigator.
Refusal to participate in the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Oyaguchi Kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Oyaguchi Kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
okumura.yasuo@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Johnson & Johnson
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1 Oyaguchi Kamicho, Itabashi-ku, Tokyo, Japan
Tel
03-3972-8111
med.rinsyokenkyu@nihon-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 | 17 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 08 | Month | 31 | Day |
Other
Other related information
This is a prospective multicenter observational study designed to compare the differences in tissue healing and clinical outcomes after pulsed field ablation (PFA) and radiofrequency ablation (RFA). Patients who provide written informed consent prior to ablation will be enrolled and followed up for 12 months post-procedure. Evaluations include ECG, echocardiography, blood tests, and CT imaging. The primary endpoint is early recurrence of atrial arrhythmia within 3 months after ablation. Secondary endpoints include GP response elimination, arrhythmia recurrence, cardiac function, and changes in biomarkers. A total of 60 patients will be enrolled. Comparative analysis between the PFA and RFA groups will be performed.
Management information
Registered date
| 2025 | Year | 05 | Month | 17 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065876
