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

Comparison of Intravascular Hemolysis and Lesion Characteristics After Pulmonary Vein Isolation for Atrial Fibrillation Using FARAPULSE and PulseSelect Pulsed Field Ablation Systems.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1032250726

Enrollment

300

Registered

2026-02-12

Start date

2026-02-12

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

Atrial fibrillation

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients aged 18 years or older -Patients scheduled to undergo pulsed field ablation (PFA) for atrial fibrillation at participating institutions

Exclusion criteria

Exclusion criteria: -Patients who are unable to provide written informed consent to participate in the study -Patients with a history of prior pulmonary vein isolation

Design outcomes

Primary

Measure	Time frame
-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

Measure	Time frame
-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).	—

Measure

Time frame

-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).

—

Contacts

Public ContactMami Narita

Mito Saiseikai General Hospital

mami.narita.622@gmail.com+81-29-254-5151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026