臨床研究等提出・公開システム

Date of registration	May. 19, 2025
Last modified on	Dec. 22, 2025
Trial ID	jRCT1072250022

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

Contact for Scientific Queries	Name	Okamatsu Hideharu
	Affiliation	SaiseikaiKumamotoHospital
	Address	5-3-1 Chikami Minami-ku Kumamoto city Kumamoto
	Telephone	+81-96-351-8000
	E-mail	hideharu-okamatsu@saiseikaikumamoto.jp
Contact for Public Queries	Name	Okamatsu Hideharu
	Affiliation	SaiseikaiKumamotoHospital
	Address	5-3-1 Chikami Minami-ku Kumamoto city Kumamoto
	Telephone	+81-96-351-8000
	E-mail	hideharu-okamatsu@saiseikaikumamoto.jp

Recruitment status	Not Recruiting

Study Design
Anticipated date of first enrollment		April. 09, 2025
Target sample size		60
Study Type		Observational



	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing initial atrial fibrillation ablation with Farapulse system or PulseSelect sys
	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
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		atrial fibrillation
Health Condition(s) Code		D001281
Primary Outcome(s)		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 Outcome(s)		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.

Primary Sponsor	none

Name of Certified Review Board	Saiseikai Kumamoto Hospital Ethics Committee
Address	5-3-1 Chikami Minami-ku Kumamoto city Kumamoto, Kumamoto
Telephone	+81-96-351-8000
E-Mail	rks@saiseikaikumamoto.jp
Approval Status	Approval
Date of approval	April. 16, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Dec. 22, 2025	(this page)	Changes
1	May. 19, 2025	Detail

List of change history