UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059329 |
|---|---|
| Receipt number | R000067846 |
| Scientific Title | Tissue Proximity Indication-Guided Pulsed Field Ablation for Atrial Fibrillation: A Multicenter observational Study |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/07 16:42:41 |
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Basic information
Public title
Tissue Proximity Indication-Guided Pulsed Field Ablation for Atrial Fibrillation: A Multicenter observational Study
Acronym
TPI-PFA Study
Scientific Title
Tissue Proximity Indication-Guided Pulsed Field Ablation for Atrial Fibrillation: A Multicenter observational Study
Scientific Title:Acronym
TPI-PFA Study
Region
| Japan |
Condition
Condition
Ftrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pulsed field ablation (PFA) has recently gained widespread attention as a novel therapeutic modality for atrial fibrillation (AF). The VARIPULSE catheter system, designed specifically for PFA, incorporates a Tissue Proximity Indication (TPI) module that enables objective assessment of catheter-tissue contact through impedance-based feedback. This study aims to evaluate the safety and efficacy of TPI-guided ablation and to validate its procedural safety in real-world clinical settings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Early efficacy endpoint
Freedom from AF/AT recurrence within 3 months:
No atrial fibrillation (AF) or atrial tachycardia (AT) episodes lasting more than 30 seconds detected by electrocardiogram (ECG), Holter monitoring, or event monitoring within 3 months after ablation.
2. Long-term efficacy endpoint
Freedom from AF/AT recurrence at 12 months:
No AF or AT episodes lasting more than 30 seconds detected by ECG, Holter monitoring, or event monitoring at 12 months after ablation, excluding the 3-month blanking period.
Key secondary outcomes
1. Safety endpoints
Incidence of transient ischemic attack (TIA) and stroke, incidence of cardiac tamponade, incidence of major vascular complications, incidence of clinically relevant bleeding (major and non-major), and all-cause mortality during the procedure and follow-up period.
2. Acute pulmonary vein (PV) gaps
Incidence and anatomical distribution of acute PV gaps identified during the procedure (e.g., anterior wall, posterior wall, bifurcation sites).
3. Lesion formation parameters
Number of PFA applications per vein and per patient, percentage of TPI-positive ablations (%TPI-positive rate), presence and location of areas with sparse TPI tags (low-density regions), and number of touch-up ablations delivered to TPI-negative or low-density regions.
4. Exploratory analysis
Exploratory assessment of whether the %TPI-positive rate and estimated lesion density serve as predictors of AF/AT recurrence suppression.
5. Procedural parameters
Total procedure time, fluoroscopy time, and left atrial dwell time.
6. Long-term adverse events
Incidence of thromboembolic events, cardiovascular events (e.g., hospitalization for heart failure or acute coronary syndrome), bleeding events, and all-cause mortality during long-term follow-up.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age >=18 years. 2) Scheduled for a first catheter ablation for atrial fibrillation. 3) Use of the VARIPULSE catheter system (software Version 8). 4) Ablation performed under a TPI-guided strategy. 5) Ability and willingness to comply with planned follow-up (ECG/Holter, etc.).
Key exclusion criteria
Prior left atrial ablation. 2) Long-standing persistent or permanent AF. 3) Severe valvular disease. 4) End-stage renal disease on dialysis. 5) Active malignancy with poor prognosis. 6) Contraindications to oral anticoagulation. 7) Inability to provide informed consent. 8) Severe cognitive/psychiatric disorder precluding participation. 9) Left atrial diameter >50 mm. 10) LVEF <40%. 11) Presence of a cardiac implantable device. 12) Left atrial thrombus on TEE/CT. 13) Uncontrolled intra-procedural hypertension (SBP >180 mmHg). 14) Pregnancy or lactation. 15) Life expectancy <12 months. 16) Deemed unsuitable by the investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Caridology
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 | Hikaru |
| Middle name | |
| Last name | Masuda |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Caridology
Zip code
173-8610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
masuda.hikaru@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine Itabashi Hospital
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, School of Medicine
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 | 10 | Month | 08 | 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 | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary Endpoints
1. Early efficacy endpoint
Freedom from AF/AT recurrence within 3 months:
No atrial fibrillation (AF) or atrial tachycardia (AT) episodes lasting more than 30 seconds detected by electrocardiogram (ECG), Holter monitoring, or event monitoring within 3 months after ablation.
2. Long-term efficacy endpoint
Freedom from AF/AT recurrence at 12 months:
No AF or AT episodes lasting more than 30 seconds detected by ECG, Holter monitoring, or event monitoring at 12 months after ablation, excluding the 3-month blanking period.
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067846
