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

NCT07490808 | Recruiting

• 1 other identifier: KS2026035
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF); Acute Kidney Injury

Keywords

Pulsed field ablation; Atrial Fibrillation; Acute kidney injury; Hydration

Outcome Measures

Primary Outcomes (1)

• In-hospital acute kidney injury

  Acute kidney injury (AKI) of any severity during hospitalization, meeting any of the following criteria according to KDIGO guidelines: 1) an increase in serum creatinine level of 0.3 mg/dL within 48 hours, or 2) an increase to at least 1.5 times baseline.

  Periprocedural

Secondary Outcomes (14)

• In-hospital AKI severity

  Periprocedural

• In-hospital persistent moderate-to-severe AKI

  Periprocedural

• In-hospital renal replacement therapy

  Periprocedural

• Absolute and relative changes in serum creatinine and eGFR after the procedure

  Periprocedural

• 30-day mortality

  Within 30 days after randomization

Study Arms (2)

Hydration group

EXPERIMENTAL

Participants assigned to the hydration group will receive 0.9% sodium chloride intravenously at 2 mL/kg/h starting when the participant enters the electrophysiology laboratory and continuing until 12 hours after the procedure. The infusion rate may be reduced or interrupted if there is evidence of fluid overload, hypoxemia, pulmonary congestion, or any other safety concern judged by the investigator.

Drug: 0.9% sodium chloride

Control group

NO INTERVENTION

Participants assigned to the control group will not receive routine preventive hydration; intravenous fluids may be given only when clinically indicated, such as for suspected hemoglobinuria, rising serum creatinine, oliguria.

Interventions

0.9% sodium chloride DRUG

Participants assigned to the hydration group will receive 0.9% sodium chloride intravenously at 2 mL/kg/h starting when the participant enters the electrophysiology laboratory and continuing until 12 hours after the procedure. The infusion rate may be reduced or interrupted if there is evidence of fluid overload, hypoxemia, pulmonary congestion, or any other safety concern judged by the investigator.

Hydration group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospitai, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Acute Kidney Injury

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Song Zuo

CONTACT

+86 010-84005361; song_zuo@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 24, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)