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

Conditions

• Intra-Abdominal Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

Mar 3, 2026

Status verified

Mar 2026

Primary completion

Dec 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Accuryn Foley catheter placement
  foley catheter is made to measure intra-abdominal pressure

Primary Outcome Measure

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

Central Contacts

• Karuna Rajkumar, MD
  832-707-0858
  [email protected]

Locations (1)

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