Comparative study of Farapulse system and PulseSelect system on hemolysis and renal dysfunction associated with pulsed field ablation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1072250022

Enrollment

Registered

2025-05-19

Start date

2025-04-09

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing initial atrial fibrillation ablation with Farapulse system or PulseSelect sys

Exclusion criteria

Exclusion criteria: If any of the following applies Patients currently participating in another clinical trial or clinical study (interventional study) Left ventricular ejection fraction of 35% or less Left atrial diameter of 55 mm or greater Long-term persistent atrial fibrillation lasting more than 3 years Renal dysfunction with serum creatinine >= 1.5 mg/dl Postoperative valvular disease (including catheterization) Post Maze surgery Severe valvular disease Active malignancy Patients treated with Pulsed field ablation other than pulmonary vein isolation

Design outcomes

Primary

Measure	Time frame
The following items will be compared between the two treatment devices The degree of increase in free hemoglobin immediately before sheath removal during the ablation procedure, 3 hours after the procedure, and the morning of the next day. The degree of increase in Cre immediately before sheath removal during the ablation procedure, 3 hours after the procedure, and the morning of the next day after the procedure. Frequency of occurrence of Stage 1 or higher renal failure according to KDIGO practice guidelines	—

Measure

Time frame

The following items will be compared between the two treatment devices The degree of increase in free hemoglobin immediately before sheath removal during the ablation procedure, 3 hours after the procedure, and the morning of the next day. The degree of increase in Cre immediately before sheath removal during the ablation procedure, 3 hours after the procedure, and the morning of the next day after the procedure. Frequency of occurrence of Stage 1 or higher renal failure according to KDIGO practice guidelines

—

Secondary

Measure	Time frame
The following items will be compared between the two treatment devices. The degree of increase in total bilirubin and LDH immediately before sheath removal during the ablation procedure, 3 hours after the procedure, and the morning of the next day. The degree of decrease in serum hemoglobin immediately before sheath removal during the ablation procedure, 3 hours after the procedure, and the morning of the day after the procedure. The degree of increase in BUN immediately before sheath removal during the ablation procedure, 3 hours after the procedure, and the morning of the next day. Frequency of patients with haptoglobulin levels below the sensitivity level on the day after surgery.	—

Measure

Time frame

The following items will be compared between the two treatment devices. The degree of increase in total bilirubin and LDH immediately before sheath removal during the ablation procedure, 3 hours after the procedure, and the morning of the next day. The degree of decrease in serum hemoglobin immediately before sheath removal during the ablation procedure, 3 hours after the procedure, and the morning of the day after the procedure. The degree of increase in BUN immediately before sheath removal during the ablation procedure, 3 hours after the procedure, and the morning of the next day. Frequency of patients with haptoglobulin levels below the sensitivity level on the day after surgery.

—

Contacts

Public ContactHideharu Okamatsu

SaiseikaiKumamotoHospital

hideharu-okamatsu@saiseikaikumamoto.jp+81-96-351-8000

Outcome results