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
This study will test whether giving IV saline around the time of pulsed field ablation can lower the chance of acute kidney injury in adults with symptomatic paroxysmal or persistent atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Anzhen Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07490808 on ClinicalTrials.gov |
What this trial studies
Pulsed field ablation (PFA) is a non‑thermal catheter approach for treating atrial fibrillation that has raised concerns about peri‑procedural hemolysis and subsequent acute kidney injury (AKI). This single‑center, open‑label randomized trial will assign eligible adults 1:1 to a standardized hydration protocol (0.9% saline at 2 mL/kg/h from electrophysiology lab entry until 12 hours after the procedure) or to a control group that receives fluids only if clinically indicated. The primary outcome is in‑hospital AKI after PFA, with enrollment targeted at 290 participants at Beijing Anzhen Hospital. The design tests whether routine peri‑procedural IV hydration reduces AKI compared with usual care without prophylactic fluids.
Who should consider this trial
Good fit: Adults (≥18) with symptomatic paroxysmal or persistent atrial fibrillation who have failed at least one Class I or III antiarrhythmic drug and are scheduled for pulsed field ablation are the intended participants.
Not a fit: Patients not undergoing PFA, those without risk factors for peri‑procedural hemolysis, or patients with fluid‑overload conditions (for whom extra IV fluids are unsafe) are unlikely to receive benefit.
Why it matters
Potential benefit: If successful, routine peri‑procedural IV hydration could lower the rate of AKI after PFA and help protect short‑term kidney function.
How similar studies have performed: There are observational reports linking PFA‑related hemolysis to AKI but no randomized trials have yet tested routine peri‑procedural hydration for this purpose.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Anzhen Hospitai, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Song Zuo
- Email: song_zuo@126.com
- Phone: +86 010-84005361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.