NCT07490808 Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation

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This trial targets 290 participants in total. It began in 2026-03-20 with a primary completion date of 2026-07.

Brief Summary

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

Inclusion Criteria: Participants must meet all of the following criteria: * Age ≥18 years. * Symptomatic paroxysmal atrial fibrillation (AF) or persistent AF: 1. Paroxysmal AF: AF that terminates spontaneously or with intervention within 7 days of onset, and meets both of the following: 1. At least 2 symptomatic paroxysmal AF episodes within 6 months before enrollment; 2. At least 1 documented AF episode by electrocardiogram (ECG) or Holter monitoring within 12 months before enrollment. 2. Persistent AF: AF lasting \>7 days and ≤365 days, and meets both of the following: 1. At least 1 symptomatic persistent AF episode within 6 months before enrollment; 2. Persistent AF documented within 12 months before enrollment by either Holter monitoring or 2 ECGs obtained at least 7 days apart. * Failure of antiarrhythmic drug (AAD) therapy, defined as inadequate efficacy and/or intolerance to at least 1 Class I or Class III AAD. * Planned to undergo pulsed field ablation (PFA). * Willing and able to provide written informed consent. * Willing and able to comply with study procedures, including in-hospital assessments and 30-day and 90-day follow-up. Exclusion Criteria: Participants meeting any of the following criteria will be excluded: * 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. * Significant valvular heart disease, including moderate or severe aortic stenosis, severe aortic regurgitation, moderate or severe mitral stenosis, or severe mitral regurgitation. * Myocardial infarction within 3 months before enrollment. * Cardiac surgery within 3 months before enrollment. * New York Heart Association (NYHA) class III or IV congestive heart failure. * Left ventricular ejection fraction (LVEF) \<35%. * Hypertrophic cardiomyopathy. * Severe liver disease (Child-Pugh score \>7). * Stage 4 or 5 chronic kidney disease (eGFR \<30 mL/min/1.73 m²). * History of kidney transplantation. * Need for renal replacement therapy (RRT) at enrollment or any history of prior RRT. * Intravascular iodinated contrast administration within 7 days before enrollment. * Active systemic infection. * Known pregnancy or breastfeeding. * Participation in another clinical trial that may affect the results of this study. * Unwillingness or inability to comply with study procedures and follow-up, including participants considered by the investigator to be at substantial risk for poor adherence.

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