UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060626 |
|---|---|
| Receipt number | R000068664 |
| Scientific Title | LA-ICE assessment of initial fluoroscopic positioning of the pentaspline PFA catheter during pulmonary vein isolation |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/09 14:54:26 |
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Basic information
Public title
A retrospective study on the usefulness of left atrial intracardiac echocardiography (LA-ICE) during pulsed-field ablation
Acronym
LA-ICE Study
Scientific Title
LA-ICE assessment of initial fluoroscopic positioning of the pentaspline PFA catheter during pulmonary vein isolation
Scientific Title:Acronym
LA-ICE Positioning 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 was to determine the proportion of pulmonary veins that required catheter repositioning when initial fluoroscopy-guided catheter positioning was reassessed using left atrial intracardiac echocardiography (LA-ICE), and to evaluate the rate of first-pass pulmonary vein isolation achieved after LA-ICE-guided catheter repositioning.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of pulmonary veins in which initial fluoroscopy-guided pulsed field ablation catheter positioning was judged to provide inadequate catheter-tissue contact when reassessed using intracardiac echocardiography, with the echocardiography probe positioned within the left atrium.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who underwent pfa using the farapulse pentaspline catheter for atrial fibrillation, with documented use or non use of ice such as acunav or soundstar, with intra and post procedural videos allowing assessment of pulmonary vein isolation and first pass isolation, and who provided opt out consent. initial pfa cases performed at our institution.
Key exclusion criteria
patients who underwent ablation using energy sources other than pfa in combination with pfa, or cases with missing intra procedural ice or fluoroscopic recordings making isolation assessment difficult.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshiya |
| Middle name | |
| Last name | Orita |
Organization
Shinkoga Hospital, Tenjinkai Social Medical Corporation
Division name
Department of Cardiology
Zip code
830-857
Address
120 Tenjin-machi, Kurume, Fukuoka, Japan
TEL
0942-38-2222
y-orita@tenjinkai.or.jp
Public contact
Name of contact person
| 1st name | Yoshiya |
| Middle name | |
| Last name | Orita |
Organization
Shinkoga Hospital, Tenjinkai Social Medical Corporation
Division name
Department of Cardiology
Zip code
830-857
Address
Department of Cardiology
TEL
0942-38-2222
Homepage URL
y-orita@tenjinkai.or.jp
Sponsor or person
Institute
Shinkoga Hospital, Tenjinkai Social Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Shinkoga Hospital, Tenjinkai Social Medical Corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Shinkoga Hospital, Tenjinkai Social Medical Corporation
Address
120 Tenjin-machi, Kurume, Fukuoka, Japan
Tel
0942-38-2222
r-tamura@tenjinkai.or.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 | 02 | Month | 10 | 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
20
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
| 2025 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-center, retrospective observational study evaluating pulmonary vein isolation procedures performed using pulsed-field ablation (PFA).
Consecutive patients who underwent de novo PFA with a pentaspline PFA catheter were included. The initial catheter positioning performed under fluoroscopic guidance was retrospectively assessed using left atrial intracardiac echocardiography (LA-ICE) images obtained during routine clinical practice.
The primary objective of this study is to evaluate the concordance between fluoroscopy-guided initial catheter positioning and actual catheter location confirmed by LA-ICE, and to assess the validity of fluoroscopic positioning during PFA procedures.
All data were derived from routine clinical records and imaging, and the study was conducted using an opt-out consent approach.
Management information
Registered date
| 2026 | Year | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068664
