臨床研究等提出・公開システム

Date of registration	Aug. 26, 2026
Last modified on	Sept. 01, 2026
Trial ID	jRCT1071260081

Scientific Title	A Study Examining the Correlation Between the Severity of Postoperative Tubular Dysfunction and Elevated Free Hemoglobin Levels in Atrial Fibrillation Ablation Using Pulsed Field Ablation
Public Title	A Study Examining the Correlation Between the Severity of Postoperative Tubular Dysfunction and Elevated Free Hemoglobin Levels in Atrial Fibrillation Ablation Using Pulsed Field Ablation

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

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 21, 2026
Actual date of first enrollment		Aug. 25, 2026
Target sample size		30
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing their first atrial fibrillation ablation using pulsed-field ablation.
	Exclusion Criteria	Patients currently participating in other clinical trials or clinical studies (interventional studies) Renal impairment with an eGFR less than 30 mL/min/1.73 m2 Post-valvular surgery(including catheter-based treatments) Patients who have undergone Maze surgery Severe valvular heart disease Active malignant tumors Positive for leukocytes or bacteria in urine Patients who received contrast media or NSAIDs intraoperatively within 2 weeks prior to surgery HbA1c >= 6.5% History of glomerulonephritis Patients with abnormally high levels of urinary L-FABP and urinary NGAL as determined by outpatient testing
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Atrial fibrillation
Health Condition(s) Keyword		Atrial fibrillation
Health Condition(s) Code		D001281
Primary Outcome(s)		To investigate whether there is a correlation between T2 free hemoglobin levels and increases in each of the parameters of tubular dysfunction
Secondary Outcome(s)		To investigate whether there is a significant interaction between the volume of perioperative fluid administration and the degree of tubular dysfunction in relation to elevated free hemoglobin levels. To investigate whether there is a correlation between the degree of elevation in serum creatinine and BUN at T5 and the degree of elevation in each parameter of tubular dysfunction.

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	July. 17, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 01, 2026	(this page)	Changes
1	Aug. 26, 2026	Detail

List of change history