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Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter

Comparative Study of Intra-abdominal Pressure Using Accuryn Monitoring System During Pulsed Field Ablation (PFA) for Treatment of Atrial Fibrillation and/or Atrial Flutter Under Sedation.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study measures pressure inside the belly during pulsed field ablation, a treatment that uses electrical pulses for an irregular heartbeat. It uses the Accuryn monitoring system to compare pressure with the type of anesthesia used. It is for adults being treated for atrial fibrillation or atrial flutter, two types of irregular heartbeat.

The purpose of this study is to investigate the intra-abdominal pressure utilizing the Accuryn monitoring system during pulsed field ablation procedures in the electrophysiology lab compared to the type of anesthetic utilized.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult getting pulsed field ablation as regular care for atrial fibrillation, atrial flutter, or both.
  • You can safely have a Foley catheter, a tube that drains urine from your bladder, and have pressure inside your belly monitored.

Who can't join

  • You are younger than 18.
  • You have had surgery inside your belly in the past 6 months.
  • You have a medical reason that makes a bladder catheter or catheter ablation unsafe.
  • You have a history of prostate problems, including an enlarged prostate, or frequent urinary tract infections.
  • You are pregnant or breastfeeding.
  • You have a history of COPD, a long-term lung disease, and use oxygen at home.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adult patients receiving pulse field ablation procedures for standard of care treatment of atrial fibrillation and/or atrial flutter. * Eligible for Foley catheter placement with no contraindications to Intra-abdominal pressure (IAP) monitoring. Exclusion Criteria: * Patients under the age of 18 will be excluded. * History of intra-abdominal surgery within the past 6 months. * Known contraindications to bladder catheterization or catheter ablation; history of prostate issues / Benign prostatic hyperplasia (BPH) or frequent urinary tract infections * Pregnant or breastfeeding individuals * History of chronic obstructive pulmonary disease (COPD) with home oxygen use

Study sites (1)

NC