UMIN-ICDS Clinical Trial

Public title

Changes in Local Impedance Before and After Pulsed Field Ablation for Atrial Fibrillation

Acronym

PFA-LI Study

Scientific Title

Prospective Evaluation of Local Impedance Changes Following FARAPULSE Pulsed Field Ablation for Atrial Fibrillation Using OPAL HDx/FARAVIEW Mapping

Scientific Title:Acronym

FARA-PFA-LI Study

Region

Japan

Condition

Atrial fibrillation and typical atrial flutter

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate changes in local impedance (LI) before and after pulsed field ablation (PFA) using FARAWAVE and the OPAL HDx/FARAVIEW mapping system for pulmonary vein isolation in patients with atrial fibrillation who also undergo cavotricuspid isthmus (CTI) ablation using the IntellaNav STABLEPOINT catheter for typical atrial flutter.

LI changes will be assessed at the pulmonary vein antra and non-ablated atrial regions. The associations between LI changes, effective lesion formation, and successful pulmonary vein isolation will also be investigated. Additionally, the incidence of unintended superior vena cava isolation and its association with LI reduction in the superior vena cava will be explored.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Changes in local impedance (LI) before and after ablation. LI will be measured immediately before and after ablation at treated and untreated sites in the pulmonary vein regions, left atrium, and superior vena cava, and the changes in LI will be evaluated.

Key secondary outcomes

1. Concordance between PFA lesion areas visualized by the three-dimensional mapping system (identified using Field tags) and areas showing LI reduction (immediately after ablation).
2. Incidence of unintended electrical isolation of the superior vena cava and its association with LI changes in the superior vena cava (immediately after ablation).
3. Association between LI changes and changes in local electrogram amplitude (before and after ablation).
4. Changes in LI at sites requiring additional ablation (before and after additional ablation).
5. Incidence of procedure-related complications, including in-hospital death, vascular access-site complications, acute kidney injury requiring dialysis, symptomatic stroke, persistent phrenic nerve palsy, pericardial effusion, surgical intervention, and prolongation of hospitalization for any reason (from the procedure through hospital discharge).
6. Recurrence of atrial arrhythmias during hospitalization and at 1 and 3 months after the procedure.

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

As part of standard clinical care, patients will undergo pulmonary vein isolation using pulsed field ablation (PFA) with FARAWAVE for atrial fibrillation and cavotricuspid isthmus (CTI) ablation using IntellaNav STABLEPOINT for typical atrial flutter.

As study specific interventions beyond standard clinical care, additional three-dimensional mapping of the right atrium and superior vena cava will be performed using IntellaMap Orion, and local impedance (LI) measurements will be obtained using IntellaNav STABLEPOINT.

LI will be measured before and after PFA at 22 predefined sites in the pulmonary vein and left atrial regions and at two predefined sites in the superior vena cava. Measurement sites will be tagged on the three-dimensional mapping system to enable assessment at corresponding locations before and after ablation.

LI measurements will be performed with a contact force of 5 to 10 g, aiming to maintain a difference of no more than 2 g between pre and post ablation measurements. Catheter orientation and cardiac rhythm conditions will be kept as consistent as possible. LI values will be acquired without being visible to the operator.

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients diagnosed with both atrial fibrillation (AF) and atrial flutter (AFL) by 12 lead electrocardiography or Holter electrocardiography.
2. Patients considered appropriate by the treating physician, in accordance with the relevant Japanese clinical practice guidelines, for pulmonary vein isolation using the FARAPULSE pulsed field ablation (PFA) system with OPAL HDx/FARAVIEW mapping and cavotricuspid isthmus (CTI) ablation using IntellaNav STABLEPOINT.
3. Patients aged 18 years or older, with no upper age limit or sex restriction.
4. Patients for whom appropriate informed consent for study participation has been obtained from the patient or a legally authorized representative.

Key exclusion criteria

Patients for whom informed consent for study participation cannot be obtained from the patient or a legally authorized representative.

Target sample size

30

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

Email

daisuke.togashi@marianna-u.ac.jp

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

Email

daisuke.togashi@marianna-u.ac.jp

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name

Organization

None.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

St. Marianna University School of Medicine

Address

Sugao Miyamae-ku 2-16-1, Kawasaki, Japan

Tel

044-977-8111

Email

daisuke.togashi@marianna-u.ac.jp

Secondary IDs

YES

Study ID_1

7465

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

聖マリアンナ医科大学病院(神奈川県)

Date of disclosure of the study information

2026

Year

10

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

10

Month

23

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

10

Day

Last follow-up date

2028

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related 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=R000072485