Multicenter study comparing tissue healing after pulsed field ablation versus radiofrequency ablation for atrial fibrillation

Multicenter Clinical Study for Comparing Tissue Healing Processes After Atrial Fibrillation Ablation of Pulsed Field Ablation versus Radiofrequency Ablation - TISSUE HEAL PFA study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057894

Enrollment

Registered

2025-05-17

Start date

2024-11-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Atrial Fibrillation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age between 18 and 80 years at the time of ablation. Patients with symptomatic paroxysmal atrial fibrillation refractory to pharmacological therapy (ineffectiveness of at least one class I-IV antiarrhythmic drug). Patients with non-valvular atrial fibrillation undergoing first-time catheter ablation. Patients who have received sufficient explanation regarding the study, fully understand its content, and have provided written informed consent of their own free will.

Exclusion criteria

Exclusion criteria: Presence of left atrial thrombus detected on pre-procedural imaging. Left ventricular ejection fraction (LVEF) < 40%. Diagnosis of hypertrophic cardiomyopathy or severe valvular heart disease. Receiving maintenance hemodialysis. Any other condition deemed inappropriate for study participation by the principal investigator. Refusal to participate in the study.

Design outcomes

Primary

Measure	Time frame
Early recurrence of atrial fibrillation during the 3-month post-ablation blanking period	—

Secondary

Measure	Time frame
[Ablation Parameters] Elimination rate of vagal responses in five major ganglionated plexi (GP) regions, which demonstrated positive vagal responses to high-frequency stimulation (HFS) prior to ablation, re-evaluated post-ablation. Presence of vagal responses during ablation. RFA params: power, impedance, irrigation flow rate, RF delivery time, temperature, contact force (CF), force-time integral (FTI), ablation index (AI), and VisiTag data [percentage of lesions meeting criteria for catheter tip stability (within a predefined range of movement) and minimum CF during a set time]. PFA params: number of PFA applications per pulmonary vein; proportion of applications with positive tissue proximity indication (TPI). Number and locations of pulmonary vein reconnections. Total ablation time. LA dwell time: the time from initial catheter access to the left atrium to its removal after the final ablation lesion. Procedure time. Fluoro time. [Outcomes at 12 Months Post-Ablation] Clinical AF recurrence beyond the 3-month blanking period. Stroke, transient ischemic attack (TIA), or systemic embolism. CV events: stroke/TIA, MI/UA, CV death, sudden cardiac death, or admission due to HF. Major bleeding (ISTH). All-cause mortality. Clinically significant bleeding. MI or UA. Admission due to HF or other CV causes. CV death. [Changes from Baseline to 12 Months] Body weight. Blood pressure and heart rate. Lab tests: WBC, Hb, CK, CK-MB, Cr, BUN, UA, hs-CRP, INR, APTT, D-dimer, TnT, HbA1c, T-cho, LDL, HDL, TG, NT-proBNP (or BNP). Symptoms. QoL (SF-12). Heart rate variability (HRV). Use of AADs and anticoagulants. Echo: LAD, LAV, LAVI, LVEF, LVMI, E/e', valvular disease. 3D CT: LA and EAT volumes (1 mo pre-procedure and 12 mo post).	—

Measure

Time frame

[Ablation Parameters] Elimination rate of vagal responses in five major ganglionated plexi (GP) regions, which demonstrated positive vagal responses to high-frequency stimulation (HFS) prior to ablation, re-evaluated post-ablation. Presence of vagal responses during ablation. RFA params: power, impedance, irrigation flow rate, RF delivery time, temperature, contact force (CF), force-time integral (FTI), ablation index (AI), and VisiTag data [percentage of lesions meeting criteria for catheter tip stability (within a predefined range of movement) and minimum CF during a set time]. PFA params: number of PFA applications per pulmonary vein; proportion of applications with positive tissue proximity indication (TPI). Number and locations of pulmonary vein reconnections. Total ablation time. LA dwell time: the time from initial catheter access to the left atrium to its removal after the final ablation lesion. Procedure time. Fluoro time. [Outcomes at 12 Months Post-Ablation] Clinical AF recurrence beyond the 3-month blanking period. Stroke, transient ischemic attack (TIA), or systemic embolism. CV events: stroke/TIA, MI/UA, CV death, sudden cardiac death, or admission due to HF. Major bleeding (ISTH). All-cause mortality. Clinically significant bleeding. MI or UA. Admission due to HF or other CV causes. CV death. [Changes from Baseline to 12 Months] Body weight. Blood pressure and heart rate. Lab tests: WBC, Hb, CK, CK-MB, Cr, BUN, UA, hs-CRP, INR, APTT, D-dimer, TnT, HbA1c, T-cho, LDL, HDL, TG, NT-proBNP (or BNP). Symptoms. QoL (SF-12). Heart rate variability (HRV). Use of AADs and anticoagulants. Echo: LAD, LAV, LAVI, LVEF, LVMI, E/e', valvular disease. 3D CT: LA and EAT volumes (1 mo pre-procedure and 12 mo post).

—

Countries

Japan

Contacts

Public ContactYasuo Okumura

Nihon University School of Medicine Division of Cardiology, Department of Medicine

okumura.yasuo@nihon-u.ac.jp03-3972-8111

Outcome results