Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07490808

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

Led by Beijing Anzhen Hospital · Updated on 2026-04-17

290

Participants Needed

1

Research Sites

27 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Symptomatic paroxysmal atrial fibrillation (AF) with at least 2 symptomatic episodes in the past 6 months and at least 1 documented episode within 12 months
  • Persistent AF lasting more than 7 days but less than or equal to 365 days, with at least 1 symptomatic episode in the past 6 months and documented by monitoring within 12 months
  • Failure of antiarrhythmic drug therapy with inadequate efficacy or intolerance to at least 1 Class I or Class III drug
  • Planned pulsed field ablation procedure
  • Willing and able to provide written informed consent
  • Willing and able to comply with study procedures including hospital assessments and follow-up visits at 30 and 90 days
Not Eligible

You will not qualify if you...

  • Atrial fibrillation caused by reversible conditions such as hyperthyroidism or surgery-related AF
  • No oral anticoagulation for at least 3 weeks before ablation
  • Presence of intracardiac thrombus
  • Contraindication to anticoagulants or iodinated contrast media
  • Significant valvular heart disease including moderate or severe aortic stenosis or regurgitation, or severe mitral valve disease
  • Myocardial infarction within 3 months before enrollment
  • Cardiac surgery within 3 months before enrollment
  • New York Heart Association class III or IV heart failure
  • Left ventricular ejection fraction below 35%
  • Hypertrophic cardiomyopathy
  • Severe liver disease with Child-Pugh score over 7
  • Stage 4 or 5 chronic kidney disease with estimated glomerular filtration rate below 30
  • History of kidney transplantation
  • Need for or history of renal replacement therapy
  • Iodinated contrast administration within 7 days before enrollment
  • Active systemic infection
  • Known pregnancy or breastfeeding
  • Participation in another clinical trial that could affect this study
  • Unwillingness or inability to comply with study procedures and follow-up including risk of poor adherence

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Anzhen Hospitai, Capital Medical University

Beijing, Beijing Municipality, China, 100029

Actively Recruiting

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Research Team

S

Song Zuo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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