Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

PFA is an emerging non-thermal ablation technology with favorable procedural safety; however, recent studies have raised concerns about peri-procedural hemolysis and subsequent AKI after PFA. This study is a single-center, open-label, randomized controlled trial designed to evaluate whether standardized peri-procedural intravenous hydration can reduce the risk of acute kidney injury (AKI) after pulsed field ablation (PFA) for atrial fibrillation (AF).

Eligible adult patients with symptomatic paroxysmal or persistent AF scheduled for PFA will be randomly assigned in a 1:1 ratio to either a standardized hydration strategy or a control strategy without routine prophylactic hydration. The hydration group will receive 0.9% saline at 2 mL/kg/h from entry into the electrophysiology laboratory until 12 hours after the procedure, while the control group will receive no routine preventive hydration and will be treated with fluids only if clinically indicated.

The primary outcome is any in-hospital AKI defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary endpoints include in-hospital AKI severity by KDIGO stage, in-hospital persistent moderate-to-severe AKI, in-hospital renal replacement therapy, changes in renal function after the procedure, and clinical outcomes through 30 and 90 days, including all-cause death, persistent AKI, renal replacement therapy, all-cause rehospitalization, and composite major adverse events.

Eligibility criteria

Qualifiers

Age ≥18 years.

At least 2 symptomatic paroxysmal AF episodes within 6 months before enrollment;

At least 1 documented AF episode by electrocardiogram (ECG) or Holter monitoring within 12 months before enrollment.

At least 1 symptomatic persistent AF episode within 6 months before enrollment;

Disqualifiers

AF due to a reversible cause, such as hyperthyroidism or perioperative/cardiothoracic surgery-related AF.

No oral anticoagulation for at least 3 weeks before ablation.

Intracardiac thrombus.

Contraindication to anticoagulant therapy or iodinated contrast media.

Trial design

Treatments tested in this trial

  • 0.9% sodium chloride

Treatment groups

290 Participants
are divided into 2 treatment groups

Sponsors and collaborators