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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1070250108

Enrollment

Registered

2025-12-03

Start date

2025-12-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation Atrial fibrillation

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing initial catheter ablation for atrial fibrillation using the VARIPULSE catheter

Exclusion criteria

Exclusion 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 ==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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Contacts

Public ContactHideharu Okamatsu

Saiseikai Kumamoto Hospital

hideharu-okamatsu@saiseikaikumamoto.jp+81-96-351-8000

Outcome results