Bladder Catheters During Ablation Procedures

S

St. Vincent Cardiovascular Research Institute

Status

Completed

Conditions

Atrial Fibrillation
Catheter Complications
Catheter Ablation

Treatments

Device: Insert bladder catheter
Device: No catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT03635034
R20180053

Details and patient eligibility

About

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.

Full 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

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

No Bladder catheter
Experimental group
Description:
Subjects will not have bladder catheter inserted during their ablation procedure. Intervention: No catheter
Treatment:
Device: No catheter
Bladder catheter inserted
Active Comparator group
Description:
Bladder catheter will be inserted prior to starting ablation procedure after the subject is under general anesthesia. Intervention: bladder catheter inserted
Treatment:
Device: Insert bladder catheter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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