Recruiting

Pulsed Field Ablation with Accuryn

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06876896

Conditions

Intra-Abdominal Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Accuryn Foley catheter device

Study Details

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

Study ID

NCT06876896

Start date

Mar 3, 2026

Status verified date

Mar, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Accuryn Foley catheter placement

foley catheter is made to measure intra-abdominal pressure

Interventions

Accuryn Foley catheter device

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

Primary outcome measure

  • Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia [ Time Frame: hour 2 ]
  • Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation [ Time Frame: hour 2 ]

Central Contacts and Locations

Central contacts

Karuna Rajkumar, MD

832-707-0858kputturr@wakehealth.edu

Locations

Wake Forest Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Karuna Rajkumar

832-707-0858kputturr@wakehealth.edu

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • Atrial Fibrillation
  • Atrial Flutter
  • Pulsed Field Ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-03-19.