NIPH Clinical Trials Search

A Study Examining the Course of Free Hemoglobin and the Degree of Renal Deterioration Following Pulmonary Vein Isolation Using PulseSelect in Patients with Atrial Fibrillation and Concomitant Renal Impairment

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Atrial fibrillation
Date of first enrollment	27/04/2026
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 disease at Stage 1 or higher according to the KDIGO clinical guidelines
Secondary Outcome	The extent of elevation in total bilirubin and LDH in T2, T3, and T4 The extent of decrease in serum hemoglobin in T2,T3, and T4 The extent of elevation in BUN in T2, T3, and T4 The frequency of patients whose haptoglobin levels fell 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 with atrial fibrillation and a serum creatinine level of 1.5 mg/dL or higher who are undergoing their first catheter ablation for atrial fibrillation using the PulseSelect system
Exclude criteria	Patients currently participating in other clinical trials or clinical studies (interventional studies) Left ventricular ejection fraction of 35% or less Left atrial diameter of 55 mm or more Long-standing atrial fibrillation lasting 3 years or longer Serum creatinine < 1.5 mg/dL Patients undergoing maintenance dialysis Post-valvular surgery (including catheter-based procedures) Post-Maze surgery Severe valvular disease Active malignancy Patients who have undergone pulsed-field ablation for indications other than pulmonary vein isolation