JRCT ID: jRCT1070250078
Registered date:30/09/2025
A Study to Confirm the Extent of Hemolysis and Renal Impairment in Radiofrequency Ablation for Atrial Fibrillation
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Atrial fibrillation |
| Date of first enrollment | 06/08/2025 |
| Target sample size | 30 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Degree of increase in free hemoglobin in T2, T3, and T4 Degree of increase in creatinine in T2, T3, and T4 Incidence of kidney injury stage1 or higher according to KDIGO clinical guidelines |
|---|---|
| Secondary Outcome | Degree of elevation in total bilirubin and LDH during T2, T3, and T4 Degree of decrease in serum hemoglobin during T2, T3, and T4 Degree of elevation in BUN during 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 | |
| Include criteria | Patients undergoing initial radiofrequency catheter ablation for atrial fibrillation |
| Exclude criteria | Patients meeting any of the following criteria: Currently participating in another clinical trial or clinical research (interventional study) 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 neoplasm |
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 |