臨床研究等提出・公開システム

Date of registration	Dec. 03, 2025
Last modified on	Dec. 03, 2025
Trial ID	jRCT1070250108

Scientific Title	A Study to Confirm the Extent of Hemolysis and Renal Impairment in VARIPULSE Catheter Ablation for Atrial Fibrillation
Public Title	A Study to Confirm the Extent of Hemolysis and Renal Impairment in VARIPULSE Catheter Ablation for Atrial Fibrillation

Contact for Scientific Queries	Name	Okamatsu Hideharu
	Affiliation	Saiseikai Kumamoto Hospital
	Address	3-1, Chikami 5-chome, Minami Ward, Kumamoto City, Kumamoto Prefecture
	Telephone	+81-96-351-8000
	E-mail	hideharu-okamatsu@saiseikaikumamoto.jp
Contact for Public Queries	Name	Okamatsu Hideharu
	Affiliation	Saiseikai Kumamoto Hospital
	Address	3-1, Chikami 5-chome, Minami Ward, Kumamoto City, Kumamoto Prefecture
	Telephone	+81-96-351-8000
	E-mail	hideharu-okamatsu@saiseikaikumamoto.jp

Recruitment status	Recruiting

Study Design
Anticipated date of first enrollment		Dec. 03, 2025
Target sample size		30
Study Type		Observational



	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing initial catheter ablation for atrial fibrillation using the VARIPULSE catheter
	Exclusion Criteria	Patients meeting any of the following criteria Patients who underwent pulmonary vein isolation using radiofrequency ablation alone Patients currently participating in other clinical trials or studies (interventional studies) Left ventricular ejection fraction =< 35% Left atrial diameter >=55 mm Renal impairment with serum creatinine >= 1.5 mg/dL Post-valvular surgery (including catheter-based treatment) Post-Maze surgery Severe valvular disease Active malignant neoplasms
	Age Minimum	No limit
	Age Maximum	No limit

Health Condition(s) or Problem(s) Studied		Atrial fibrillation
Health Condition(s) Keyword		Atrial fibrillation
Health Condition(s) Code		D001281
Primary Outcome(s)		Degree of increase in free hemoglobin Degree of increase in C-reactive protein Incidence of Stage 1 or higher kidney injury according to KDIGO clinical guidelines
Secondary Outcome(s)		Degree of elevation in total bilirubin and LDH Degree of decrease in serum hemoglobin Degree of elevation in BUN Frequency of patients with haptoglobin levels falling below the detection limit on the day after surgery

Primary Sponsor	none

Name of Certified Review Board	Saiseikai Kumamoto Hospital Ethics Committee
Address	3-1, Chikami 5-chome, Minami Ward, Kumamoto City, Kumamoto Prefecture, Kumamoto
Telephone	+81-93-351-8000
Approval Status	Approval
Date of approval	Nov. 14, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none