UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063270 |
|---|---|
| Receipt number | R000072020 |
| Scientific Title | Incidence and Anatomical Mechanisms of Unintentional Non-Pulmonary Vein Lesion Formation During Wire-Guided Single-Shot Pulsed-Field Ablation |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/14 12:20:04 |
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Basic information
Public title
Incidence and Anatomical Mechanisms of Unintentional Non-Pulmonary Vein Lesion Formation During Wire-Guided Single-Shot Pulsed-Field Ablation
Acronym
UNVEIL-PFA study
Scientific Title
Incidence and Anatomical Mechanisms of Unintentional Non-Pulmonary Vein Lesion Formation During Wire-Guided Single-Shot Pulsed-Field Ablation
Scientific Title:Acronym
UNVEIL-PFA study
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the incidence and clinical characteristics of unintentional lesion formation involving structures adjacent to the pulmonary veins, particularly the left atrial appendage and mitral isthmus, during pulmonary vein isolation using wire-guided single-shot pulsed-field ablation (PFA). In addition, we aim to investigate potential anatomical and procedural mechanisms underlying these lesions using preprocedural cardiac computed tomography measurements of the spatial relationships between the pulmonary veins and adjacent structures, together with ex vivo assessment of PFA catheter geometry using an anatomical heart model.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of unintentional lesion formation involving the left atrial appendage or mitral isthmus identified by electroanatomical mapping immediately after pulmonary vein isolation using wire-guided single-shot PFA. Unintentional lesion formation is defined as a newly identified low-voltage area, conduction disturbance, or electrical isolation involving the left atrial appendage or mitral isthmus that was not an intended ablation target.
Key secondary outcomes
1. Incidence of left atrial appendage and mitral isthmus lesions according to the PFA system (FARAPULSE or PulseSelect).
2. Proportion of complete left atrial appendage isolation among patients with LAA involvement and complete conduction block among patients with mitral isthmus involvement.
3. Association between unintentional lesion formation and anatomical distances measured on preprocedural cardiac CT, including the distance between the left superior pulmonary vein and left atrial appendage and between the left inferior pulmonary vein and mitral annulus.
4. Degree of catheter protrusion toward the left atrial appendage and mitral annulus measured using FARAWAVE and PulseSelect catheters in an anatomical heart model.
5. Recurrence of atrial fibrillation or atrial tachycardia during clinical follow-up among patients with unintentional lesion formation.
6. Chronic reconduction and persistence of low-voltage lesions at the site of unintentional lesion formation in patients undergoing repeat ablation procedures.
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
1. Patients who underwent catheter ablation for atrial fibrillation.
2. Patients who underwent pulmonary vein isolation using a wire-guided single-shot PFA system, either FARAPULSE or PulseSelect.
3. Patients in whom post-ablation three-dimensional electroanatomical mapping was performed to assess pulmonary vein isolation and lesion distribution within the left atrium.
Key exclusion criteria
1. Patients treated using PFA systems other than FARAPULSE or PulseSelect.
2. Patients without adequate post-ablation electroanatomical mapping for assessment of lesion distribution.
3. Patients with insufficient clinical or imaging data required for the study analyses.
Target sample size
655
Research contact person
Name of lead principal investigator
| 1st name | Koumei |
| Middle name | |
| Last name | Onuki |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
802-0001
Address
3-2-1 Asano, Kokurakita Ward, Kitakyushu City, Fukuoka Prefecture
TEL
+81-93-511-2000
umixsirakawa@gmail.com
Public contact
Name of contact person
| 1st name | Koumei |
| Middle name | |
| Last name | Onuki |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
802-0001
Address
3-2-1 Asano, Kokurakita Ward, Kitakyushu City, Fukuoka Prefecture
TEL
+81-93-511-2000
Homepage URL
umixsirakawa@gmail.com
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Koumei Onuki
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kokura Memorial Hospital
Address
3-2-1 Asano, Kokurakita Ward, Kitakyushu City, Fukuoka Prefecture
Tel
+81-93-511-2000
umixsirakawa@gmail.com
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 | 10 | Month | 15 | 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
655
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
Completed
Date of protocol fixation
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072020
