Accuryn Foley Catheter Device for Atrial Tachycardia

(IAP Trial)

Overseen By Karuna Rajkumar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Intra-abdominal surgery, BPH, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Karuna Rajkumar, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for patients with atrial tachycardia or abdominal compartment syndrome. Specific eligibility criteria are not provided, so it's important to contact the study team for details on who can participate.

Inclusion Criteria

I am an adult getting pulse field ablation for atrial fibrillation/flutter.

I can safely have a Foley catheter and pressure monitoring inside my abdomen.

Exclusion Criteria

Pregnant or breastfeeding individuals

I have not had surgery in my belly area in the last 6 months.

I do not have issues with bladder procedures or a history of prostate problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Pulsed Field Ablation (PFA) with intra-abdominal pressure monitoring using the Accuryn system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including tracking of urinary tract infections and unplanned hospital admissions

1 week

1 visit (in-person)

Treatment Details

Interventions

• Accuryn Foley Catheter Device

Trial Overview The study is testing how intra-abdominal pressure changes using the Accuryn Foley catheter device during pulsed field ablation procedures for heart rhythm disorders, and comparing this with different types of anesthesia used.

Participant Groups

Group I: Accuryn Foley catheter placement Experimental Treatment 1 Intervention

foley catheter is made to measure intra-abdominal pressure

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+