NCT07490808Completed
Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation
Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation: A Single-Center, Open-Label, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 290 (actual)
- First submitted
- 10 Mar 2026
- Start date
- 20 Mar 2026
- Primary completion date
- 19 Jul 2026
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07490808
What you commit to
- Study type: Interventional
- Participants enrolled: 290
- From 20 Mar 2026 to the primary completion date, 19 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Contraindication to anticoagulant therapy or iodinated contrast media.
- Myocardial infarction within 3 months before enrollment.
- Cardiac surgery within 3 months before enrollment.
- Need for renal replacement therapy (RRT) at enrollment or any history of prior RRT.
- Intravascular iodinated contrast administration within 7 days before enrollment.
Other illness
- Significant valvular heart disease, including moderate or severe aortic stenosis, severe aortic regurgitation, moderate or severe mitral stenosis, or severe mitral regurgitation.
- New York Heart Association (NYHA) class III or IV congestive heart failure.
- Severe liver disease (Child-Pugh score \>7).
- History of kidney transplantation.
- Active systemic infection.
Lab values
- Left ventricular ejection fraction (LVEF) \<35%.
- Stage 4 or 5 chronic kidney disease (eGFR \<30 mL/min/1.73 m²).
Other
- Participants meeting any of the following criteria will be excluded:
- Intracardiac thrombus.
- Hypertrophic cardiomyopathy.
- 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.
Who the study is looking for
- Participants must meet all of the following criteria:
- Age ≥18 years.
- Symptomatic paroxysmal atrial fibrillation (AF) or persistent AF:
- Paroxysmal AF: AF that terminates spontaneously or with intervention within 7 days of onset, and meets both of the following:
- 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.
- Persistent AF: AF lasting \>7 days and ≤365 days, and meets both of the following:
- At least 1 symptomatic persistent AF episode within 6 months before enrollment;
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospitai, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.