BridgeMD
New treatment option for Atrial Fibrillation (AF)
Official title Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation
ClinicalTrials.gov ID: NCT07490808
What this study is testing
What is 0.9% sodium chloride?
0.9% sodium chloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for atrial fibrillation (af).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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;
You likely can't join 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...
See the full eligibility criteria
- 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 how well it works 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.