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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1070260033
Enrollment
30
Registered
2026-05-28
Start date
2026-04-27
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

Sponsors

Okamatsu Hideharu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactHideharu Okamatsu

Saiseikai Kumamoto Hospital

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026