Bladder Catheters During Ablation Procedures

Last updated: September 29, 2021
Sponsor: St. Vincent Cardiovascular Research Institute
Overall Status: Completed

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Catheter Complications

Treatment

N/A

Clinical Study ID

NCT03635034
R20180053
  • Ages > 18
  • All Genders

Study Summary

Inserting a Bladder catheter during catheter ablation is standard practice at most Institutions. Unfortunately, bladder catheters are associated with adverse outcomes, including catheter associated cystitis, hematuria, dysuria, and urethral damage.

The investigator proposes a prospective, randomized clinical trial comparing group A that will receive a catheter during the ablation procedure and group B that will not receive the procedure. The Investigator hypothesizes the group receiving the bladder catheters will have a higher rate of complications.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All subjects presenting to the St. Vincent EP lab for AF ablation Ability to signinformed consent

Exclusion

Exclusion Criteria:

  • Recent (within 1 month) cystitis, history of urinary retention or incontinence, priorbladder catheter associated complications, hematuria, chronic kidney disease (stageII, III, IV, or V), dialysis, prostate cancer, renal cancer, bladder cancer, expectedprocedure duration >6 hours.

Study Design

Total Participants: 160
Study Start date:
January 16, 2018
Estimated Completion Date:
January 16, 2020

Study Description

(AF) is the commonest arrhythmia worldwide and accounts for significant morbidity. The mainstay of treatment for drug refractory AF is catheter ablation. A preponderance of evidence indicates better outcomes when this procedure is performed under general anesthesia; this is standard of care at our institution. However, for a variety of reasons including long procedure time, procedural intravenous fluid administration, and prolonged bedrest following the procedure, standard of care at our institution and others is for bladder catheter placement during the procedure (4). Unfortunately, bladder catheters used during cardiac surgery have been associated with adverse outcomes, including catheter associated cystitis, hematuria, dysuria, and urethral damage(

Fortunately, the landscape of AF ablation is changing rapidly, and procedure times are rapidly decreasing. Improvements in three dimensional mapping technology has allowed for less reliance on fluoroscopy and allows for real time visualization of ablation lesions. Improvements in ablation catheters have allowed for significantly reduced intravenous fluid administration during the procedure. The Site has also adopted an expedited protocol for venous hemostasis following the procedure that involves a figure-of-eight groin stitch, allowing for earlier mobility and a shorter bed rest following the procedure. Therefore, we question the need for routine bladder catheter placement during AF ablation procedures

Connect with a study center

  • St. Vincent Hospital and Healthcare Center

    Indianapolis, Indiana 46260
    United States

    Site Not Available

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