Atrial Fibrillation (AF)HYDRATE-PFANCT07490808
Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation
A study testing 0.9% sodium chloride in people with Atrial Fibrillation (AF) and Acute Kidney Injury, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Acute Kidney Injury
- What is being tested?
- 0.9% sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 23 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospitai, Capital Medical University
Beijing, Beijing Municipality, 100029
About this study
Official title: Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation: A Single-Center, Open-Label, Randomized Controlled Trial
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.
Read the detailed description
Pulsed field ablation (PFA) has rapidly emerged as a promising non-thermal catheter ablation technology for the treatment of atrial fibrillation (AF). Although its overall safety profile appears favorable, increasing evidence suggests that peri-procedural hemolysis may occur after PFA. In some patients, this hemolysis may contribute to acute kidney injury (AKI), which has become an important safety concern in contemporary PFA practice. Peri-procedural hydration may represent a practical kidney-protective strategy by maintaining renal perfusion and promoting clearance of hemolysis-related pigments and other nephrotoxic factors. However, no randomized controlled trial has evaluated whether routine standardized hydration reduces the risk of AKI after AF ablation with PFA.
The HYDRATE-PFA trial is a single-center, open-label, superiority, parallel-group randomized controlled trial designed to assess whether a standardized peri-procedural hydration strategy can reduce the risk of AKI after PFA for AF. A total of 290 adult patients with symptomatic paroxysmal or persistent AF who are scheduled to undergo PFA will be enrolled at Beijing Anzhen Hospital, Capital Medical University. Participants will be randomized in a 1:1 ratio to either a standardized peri-procedural hydration group, or a control group without routine prophylactic hydration.
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. 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.
For all participants, blood and urine samples will be collected at baseline, immediately after the procedure, and 24 hours after the procedure, with additional in-hospital testing if clinically indicated. Participants will also be followed at 30 days and 90 days after randomization by clinic visit or telephone contact.
The primary endpoint is any in-hospital AKI, defined according to KDIGO criteria (an increase in serum creatinine of at least 0.3 mg/dL within 48 hours or an increase to at least 1.5 times baseline). 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
- Being tested
- 0.9% sodium chloride
- Keywords
- Pulsed field ablation, Atrial Fibrillation, Acute kidney injury, Hydration
- Medical subject headings
- Atrial Fibrillation, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% sodium chlorideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural
Secondary outcomes (14)
In-hospital AKI severity
AKI Severity (defined by KDIGO staging):
- Stage 1 AKI: Serum creatinine increase ≥0.3 mg/dL or reaching 1.5-1.9 times baseline;
- Stage 2 AKI: Serum creatinine reaches 2.0-2.9 times baseline;
- Stage 3 AKI: Serum creatinine (SCr) reaches ≥3.0 times baseline, or SCr ≥4.0 mg/dL (≥353.6 μmol/L), or initiation of renal replacement therapy (RRT).
Measured: Periprocedural
In-hospital persistent moderate-to-severe AKI
Persistent moderate-to-severe AKI during hospitalization is defined as KDIGO stage 2-3 AKI lasting ≥48 hours.
AKI staging defined by KDIGO guideline:
- Stage 1 AKI: Serum creatinine increase ≥0.3 mg/dL or reaching 1.5-1.9 times baseline;
- Stage 2 AKI: Serum creatinine reaches 2.0-2.9 times baseline;
- Stage 3 AKI: Serum creatinine (SCr) reaches ≥3.0 times baseline, or SCr ≥4.0 mg/dL (≥353.6 μmol/L), or initiation of renal replacement therapy (RRT).
Measured: Periprocedural
In-hospital renal replacement therapy
In-hospital renal replacement therapy (RRT) is defined as the initiation of RRT for any reason during hospitalization.
Measured: Periprocedural
Absolute and relative changes in serum creatinine and eGFR after the procedure
Absolute and relative changes in serum creatinine and eGFR from baseline to immediately after the procedure and 24 hours after the procedure.
Measured: Periprocedural
30-day mortality
Measured: Within 30 days after randomization
30-day persistent AKI
Defined as a serum creatinine level remaining at least 50% higher than the pre-procedure baseline value at 30 days after randomization.
Measured: Within 30 days after randomization
30-day renal replacement therapy
Measured: Within 30 days after randomization
30-day all-cause rehospitalization
Measured: Within 30 days after randomization
30-day composite major adverse events
Composite of all-cause death, persistent AKI, initiation of RRT, or all-cause rehospitalization within 30 days after randomization.
Measured: Within 30 days after randomization
90-day mortality
Measured: Within 90 days after randomization
90-day persistent AKI
Defined as a serum creatinine level remaining at least 50% higher than the pre-procedure baseline value at 90 days after randomization.
Measured: Within 90 days after randomization
90-day renal replacement therapy
Measured: Within 90 days after randomization
90-day all-cause rehospitalization
Measured: Within 90 days after randomization
90-day composite major adverse events
Composite of all-cause death, persistent AKI, initiation of RRT, or all-cause rehospitalization within 90 days after randomization.
Measured: Within 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start20 Mar 2026
- Primary completion19 Jul 2026
- Study completion23 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490808
- Sponsor's protocol ID
- KS2026035
- Acronym
- HYDRATE-PFA
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation: A Single-Center, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07490808
- Acronym / sponsor ID
- HYDRATE-PFA / KS2026035
- Conditions
- Atrial Fibrillation (AF), Acute Kidney Injury
- Keywords
- Pulsed field ablation, Atrial Fibrillation, Acute kidney injury, Hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 19 Jul 2026 (actual)
- Study completion
- 23 Oct 2026 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pulsed field ablation (PFA) has rapidly emerged as a promising non-thermal catheter ablation technology for the treatment of atrial fibrillation (AF). Although its overall safety profile appears favorable, increasing evidence suggests that peri-procedural hemolysis may occur after PFA. In some patients, this hemolysis may contribute to acute kidney injury (AKI), which has become an important safety concern in contemporary PFA practice. Peri-procedural hydration may represent a practical kidney-protective strategy by maintaining renal perfusion and promoting clearance of hemolysis-related pigments and other nephrotoxic factors. However, no randomized controlled trial has evaluated whether routine standardized hydration reduces the risk of AKI after AF ablation with PFA.
The HYDRATE-PFA trial is a single-center, open-label, superiority, parallel-group randomized controlled trial designed to assess whether a standardized peri-procedural hydration strategy can reduce the risk of AKI after PFA for AF. A total of 290 adult patients with symptomatic paroxysmal or persistent AF who are scheduled to undergo PFA will be enrolled at Beijing Anzhen Hospital, Capital Medical University. Participants will be randomized in a 1:1 ratio to either a standardized peri-procedural hydration group, or a control group without routine prophylactic hydration.
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. 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.
For all participants, blood and urine samples will be collected at baseline, immediately after the procedure, and 24 hours after the procedure, with additional in-hospital testing if clinically indicated. Participants will also be followed at 30 days and 90 days after randomization by clinic visit or telephone contact.
The primary endpoint is any in-hospital AKI, defined according to KDIGO criteria (an increase in serum creatinine of at least 0.3 mg/dL within 48 hours or an increase to at least 1.5 times baseline). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydration group | Experimental | Drug: 0.9% sodium chlorideParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 years.
- Symptomatic paroxysmal atrial fibrillation (AF) or persistent AF:
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.9% sodium chlorideParticipants 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 | Hydration group |
Primary outcome
In-hospital acute kidney injury
Time frame: Periprocedural
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.
14 secondary outcomes
In-hospital AKI severity
Time frame: Periprocedural
In-hospital persistent moderate-to-severe AKI
Time frame: Periprocedural
In-hospital renal replacement therapy
Time frame: Periprocedural
Absolute and relative changes in serum creatinine and eGFR after the procedure
Time frame: Periprocedural
30-day mortality
Time frame: Within 30 days after randomization
30-day persistent AKI
Time frame: Within 30 days after randomization
30-day renal replacement therapy
Time frame: Within 30 days after randomization
30-day all-cause rehospitalization
Time frame: Within 30 days after randomization
30-day composite major adverse events
Time frame: Within 30 days after randomization
90-day mortality
Time frame: Within 90 days after randomization
90-day persistent AKI
Time frame: Within 90 days after randomization
90-day renal replacement therapy
Time frame: Within 90 days after randomization
90-day all-cause rehospitalization
Time frame: Within 90 days after randomization
90-day composite major adverse events
Time frame: Within 90 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.9% sodium chloride in people with Atrial Fibrillation (AF) and Acute Kidney Injury, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital acute kidney injury (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.