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A study comparing two pulsed field ablation systems (FARAPULSE and PulseSelect) for atrial fibrillation: evaluation of blood changes and ablation areas in the heart.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Atrial fibrillation
Date of first enrollment	12/02/2026
Target sample size	300
Countries of recruitment
Study type	Interventional
Intervention(s)	Patients scheduled to participate in this study will be randomly assigned in a 1:1 ratio to either the FARAPULSE group or the PulseSelect group by using a computer-based system (UMIN INDICE) based on the treatment date.

Outcome(s)

Primary Outcome

-Comparison of the incidence of intravascular hemolysis between the FARAPULSE and PulseSelect systems -Comparison of the pulmonary vein isolation area (lesion extent) after the initial pulsed field ablation between the FARAPULSE and PulseSelect systems

Secondary Outcome

-Exploratory analyses of factors associated with intravascular hemolysis (e.g., number of applications, age, sex, body size, left atrial volume), and investigation of the relationship between intravascular hemolysis and postoperative left atrial function. -Comparison of the proportion of pulmonary veins requiring additional ablation (reapplication of energy), total procedure time (from puncture to completion), and the incidence of adverse events (e.g., cardiac tamponade, phrenic nerve palsy).

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	-Patients aged 18 years or older -Patients scheduled to undergo pulsed field ablation (PFA) for atrial fibrillation at participating institutions
Exclude criteria	-Patients who are unable to provide written informed consent to participate in the study -Patients with a history of prior pulmonary vein isolation