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

NCT06876896 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

  • Intra-Abdominal Hypertension

Interventions

DEVICE

Accuryn Foley catheter device

Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Karuna Rajkumar, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06876896 on ClinicalTrials.gov