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) studied | Atrial fibrillation |
| Date of first enrollment | 16/09/2025 |
| Target sample size | 60 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Administration of normal saline solution for 3 hours immediately following the procedure |
Outcome(s)
| Primary Outcome | Degree 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 Outcome | Degree 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 minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Patients undergoing their first atrial fibrillation ablation at our hospital using the Farapulse system or PulseSelect system |
| Exclude criteria | Patients 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
| Primary Sponsor | Okamatsu Hideharu |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
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 |
| 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 |
| hideharu-okamatsu@saiseikaikumamoto.jp | |
| Affiliation | Saiseikai Kumamoto Hospital |