NIPH Clinical Trials Search

A Study to Confirm the Extent of Hemolysis and Renal Impairment in VARIPULSE Catheter Ablation for Atrial Fibrillation

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Atrial fibrillation
Date of first enrollment	03/12/2025
Target sample size	30
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome	Degree of increase in free hemoglobin Degree of increase in C-reactive protein Incidence of Stage 1 or higher kidney injury according to KDIGO clinical guidelines
Secondary Outcome	Degree of elevation in total bilirubin and LDH Degree of decrease in serum hemoglobin Degree of elevation in BUN 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 catheter ablation for atrial fibrillation using the VARIPULSE catheter
Exclude criteria	Patients meeting any of the following criteria Patients who underwent pulmonary vein isolation using radiofrequency ablation alone Patients currently participating in other clinical trials or studies (interventional studies) 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 neoplasms