NIPH Clinical Trials Search

JAPANESE
JRCT ID: jRCT1070250077

Registered date:30/09/2025

A Study on the Effect of Fluid Resuscitation on Renal Impairment Associated with Atrial Fibrillation Ablation Using Pulsed Field Ablation

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedAtrial fibrillation
Date of first enrollment16/09/2025
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)Administration of normal saline solution for 3 hours immediately following the procedure

Outcome(s)

Primary OutcomeDegree of increase in free hemoglobin at T2, T3, and T4 Degree of increase in creatinine at T2, T3, and T4 Incidence of Stage 1 or higher kidney injury according to KDIGO clinical guidelines
Secondary OutcomeDegree of elevation in total bilirubin and LDH in T2, T3, and T4 Degree of decrease in serum hemoglobin in T2, T3, and T4 Degree of elevation in BUN in T2, T3, and T4 Frequency of patients with haptoglobin levels falling below the detection limit on the day after surgery

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderBoth
Include criteriaPatients undergoing their first atrial fibrillation ablation at our hospital using the Farapulse system or PulseSelect system
Exclude criteriaPatients meeting any of the following criteria: Patients currently participating in other clinical trials or clinical research (interventional studies) Left ventricular ejection fraction =<35% Preoperative BNP >=400 pg/ml Left atrial diameter >=55 mm Long-standing persistent atrial fibrillation lasting >=3 years Renal impairment with serum creatinine >=1.5 mg/dl Post-valvular surgery(including catheter-based treatment) Post-Maze surgery Severe valvular heart disease Active malignant neoplasms Patients who underwent Pulsed Field Ablation treatment for reasons other than pulmonary vein isolation

Related Information

Contact

Public contact
Name Hideharu Okamatsu
Address 5-3-1 Chikami, Minami-ku, Kumamoto City, Kumamoto Prefecture Kumamoto Japan 861-4193
Telephone +81-96-351-8000
E-mail hideharu-okamatsu@saiseikaikumamoto.jp
Affiliation Saiseikai Kumamoto Hospital
Scientific contact
Name Hideharu Okamatsu
Address 5-3-1 Chikami, Minami-ku, Kumamoto City, Kumamoto Prefecture Kumamoto Japan 861-4193
Telephone +81-96-351-8000
E-mail hideharu-okamatsu@saiseikaikumamoto.jp
Affiliation Saiseikai Kumamoto Hospital