UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063392 |
|---|---|
| Receipt number | R000072440 |
| Scientific Title | Comparison of Electroanatomical Mapping Using FARAWAVE and IntellaMap Orion with the OPAL HDx/FARAVIEW System Before and After Pulsed Field Ablation for Atrial Fibrillation |
| Date of disclosure of the study information | 2026/10/23 |
| Last modified on | 2026/10/22 10:55:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of Left Atrial Mapping Using Two Different Catheters Before and After Pulsed Field Ablation for Atrial Fibrillation
Acronym
AF-PFA Mapping Comparison Study
Scientific Title
Comparison of Electroanatomical Mapping Using FARAWAVE and IntellaMap Orion with the OPAL HDx/FARAVIEW System Before and After Pulsed Field Ablation for Atrial Fibrillation
Scientific Title:Acronym
FARAWAVE/Orion Mapping 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 compare left atrial and pulmonary vein mapping performed using the FARAWAVE catheter with mapping performed using the IntellaMap Orion catheter in patients undergoing pulsed field ablation (PFA) for atrial fibrillation (AF) with the OPAL HDx/FARAVIEW system.
Agreement between the independently reconstructed left atrial geometries and bipolar voltage maps obtained using the two catheters will be assessed before and after PFA, focusing on bipolar voltage distribution, left atrial geometry volume, low-voltage area, and other mapping-derived parameters. The study will explore whether FARAWAVE-based mapping could serve as an alternative to IntellaMap Orion-based mapping. In particular, agreement between the two mapping methods will be evaluated regarding anatomical information and voltage distribution relevant to pre-PFA treatment planning, as well as information relevant to assessing treatment effects and procedural endpoints after PFA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Agreement between left atrial and pulmonary vein mapping performed using FARAWAVE and IntellaMap Orion before PFA (Pre-mapping) and after the initial PFA treatment but before any additional ablation (Post-mapping).
1. Agreement in bipolar voltage distribution: Bipolar voltage measurements will be compared within predefined anatomical regions, primarily using the median bipolar voltage amplitude (mV) for each left atrial segment. When three-dimensional coordinates and reliable spatial registration are available, agreement will also be assessed using spatially matched or nearby mapping points or voxel-based voltage measurements.
2. Agreement in quantitative mapping parameters: Left atrial geometry volume (mL), left atrial posterior wall surface area (cm2), posterior wall low-voltage area (cm2) and percentage (%), and the areas (cm2) and percentages (%) of healthy, diseased, and scar-equivalent low-voltage regions in the entire left atrium and individual anatomical segments.
Pre-mapping and Post-mapping will be analyzed separately. If detailed quantitative analysis of bipolar voltage distribution is technically infeasible, agreement will still be evaluated using the available quantitative mapping parameters.
Key secondary outcomes
1. Comparison of mapping-related parameters between FARAWAVE and IntellaMap Orion during Pre-mapping and Post-mapping: mapping time (seconds), total number of acquired mapping points, pulmonary vein myocardial sleeve length (cm), and left atrial total activation time (ms) calculated from local activation times.
2. Proportion of patients requiring additional ablation during the same procedure after the initial PFA treatment guided by field tags established with reference to FARAWAVE Pre-mapping.
3. Incidence of procedure-related complications assessed until hospital discharge: in-hospital death, vascular access-site complications, acute kidney injury requiring dialysis, symptomatic stroke, persistent phrenic nerve palsy, pericardial effusion, need for surgical intervention, and prolongation of hospitalization for any reason.
4. Recurrence of atrial arrhythmias during hospitalization and at 1 and 3 months after the procedure. Holter electrocardiography is recommended for assessment; a standard 12-lead electrocardiogram will be used when Holter monitoring is not feasible.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
In addition to standard-of-care left atrial and pulmonary vein Pre-mapping and Post-mapping using the IntellaMap Orion catheter, additional Pre-mapping and Post-mapping using the FARAWAVE catheter will be performed for research purposes.
Both mapping procedures will be performed using the OPAL HDx/FARAVIEW system, with independent reconstruction of left atrial geometry and bipolar voltage maps for each catheter. Pre-mapping will be performed before PFA, and Post-mapping will be performed after completion of the initial PFA treatment and before any additional ablation.
The acquired mapping data will be used to compare bipolar voltage distribution and quantitative mapping parameters, including left atrial geometry volume, posterior wall surface area, and low-voltage area and its proportion. PFA treatment itself will be performed as part of standard clinical care.
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
Patients who meet all of the following criteria will be eligible:
1. Patients diagnosed with atrial fibrillation (AF) by a standard 12-lead electrocardiogram or Holter electrocardiographic monitoring.
2. Patients aged 18 years or older, with no upper age limit or sex restriction.
3. Patients considered eligible by their treating cardiologist, in accordance with the relevant Japanese Circulation Society/Japanese Heart Rhythm Society guidelines, for pulmonary vein isolation, left atrial posterior wall isolation, or both, using pulsed field ablation (PFA) with the OPAL HDx/FARAVIEW and FARAPULSE systems.
4. Patients who have provided informed consent for catheter ablation and for participation in this study, either personally or through a legally authorized representative, as appropriate.
Key exclusion criteria
Patients for whom appropriate informed consent for participation in this study cannot be obtained from the patient or a legally authorized representative.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Togashi |
Organization
St. Marianna University School of Medicine
Division name
Department of Cardiology
Zip code
216-8511
Address
Sugao Miyamae-ku 2-16-1, Kawasaki, Japan
TEL
044-977-8111
daisuke.togashi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Togashi |
Organization
St. Marianna University School of Medicine
Division name
Department of Cardiology
Zip code
216-8511
Address
Sugao Miyamae-ku 2-16-1, Kawasaki, Japan
TEL
044-977-8111
Homepage URL
daisuke.togashi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
St. Marianna University School of Medicine
Address
Sugao Miyamae-ku 2-16-1, Kawasaki, Japan
Tel
044-977-8111
daisuke.togashi@marianna-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
7464
Org. issuing International ID_1
The Bioethics Committee of St. Marianna University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
聖マリアンナ医科大学病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 23 | 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
| 2026 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | 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
| 2026 | Year | 10 | Month | 23 | Day |
Last modified on
| 2026 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072440
