Tissue Proximity Indication-Guided Pulsed Field Ablation for Atrial Fibrillation: A Multicenter observational Study

Tissue Proximity Indication-Guided Pulsed Field Ablation for Atrial Fibrillation: A Multicenter observational Study - TPI-PFA Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059329

Enrollment

300

Registered

2025-10-08

Start date

2025-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ftrial Fibrillation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.).

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactHikaru Masuda

Nihon University School of Medicine Itabashi Hospital Caridology

masuda.hikaru@nihon-u.ac.jp03-3972-8111

Outcome results