Bladder Catheters During Ablation Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-16

Study Completion Date

2020-01-16

Brief Summary

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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.

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Detailed Description

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(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

Conditions

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Atrial Fibrillation Catheter Ablation Catheter Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We will compare the two groups for complications related to catheter or not having a catheter placed.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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No Bladder catheter

Subjects will not have bladder catheter inserted during their ablation procedure.

Intervention: No catheter

Group Type EXPERIMENTAL

No catheter

Intervention Type DEVICE

Subjects will not receive a bladder catheter during the ablation procedure

Bladder catheter inserted

Bladder catheter will be inserted prior to starting ablation procedure after the subject is under general anesthesia.

Intervention: bladder catheter inserted

Group Type ACTIVE_COMPARATOR

Insert bladder catheter

Intervention Type DEVICE

Bladder catheter will be inserted according to randomization schema

Interventions

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Insert bladder catheter

Bladder catheter will be inserted according to randomization schema

Intervention Type DEVICE

No catheter

Subjects will not receive a bladder catheter during the ablation procedure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All subjects presenting to the St. Vincent EP lab for AF ablation Ability to sign informed consent

Exclusion Criteria

* Recent (within 1 month) cystitis, history of urinary retention or incontinence, prior bladder catheter associated complications, hematuria, chronic kidney disease (stage II, III, IV, or V), dialysis, prostate cancer, renal cancer, bladder cancer, expected procedure duration \>6 hours.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No