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

NCT06876896 | Recruiting DMC FDA Device

• 1 other identifier: IRB00124904
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atrial Fibrillation; Atrial Flutter; Pulsed Field Ablation

Outcome Measures

Primary Outcomes (2)

• Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia

  intra-abdominal pressure during PFA when general anesthetic is utilized

  hour 2

• Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation

  intra-abdominal pressure during PFA when anesthesia is sedation

  hour 2

Secondary Outcomes (6)

• Incidence of Hiccups

  hour 2

• Amount oral secretions

  hour 2

• Number of post-operative intubations

  hour 2

• Total urine output

  hour 2

• Number of urinary tract infections

  day 7

Study Arms (1)

Accuryn Foley catheter placement

EXPERIMENTAL

foley catheter is made to measure intra-abdominal pressure

Device: Accuryn Foley catheter device

Interventions

Accuryn Foley catheter device DEVICE

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

Accuryn Foley catheter placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Intra-Abdominal Hypertension; Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karuna Rajkumar, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karuna Rajkumar, MD

CONTACT

832-707-0858; kputturr@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)