Bladder Catheters During Ablation Procedures
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|ClinicalTrials.gov Identifier: NCT03635034|
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Catheter Ablation Catheter Complications||Device: Insert bladder catheter Device: No catheter||Not Applicable|
(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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||We will compare the two groups for complications related to catheter or not having a catheter placed.|
|Masking:||None (Open Label)|
|Official Title:||Examining the Routine Use of Bladder Catheters During Atrial Fibrillation Procedures|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Experimental: No Bladder catheter
Subjects will not have bladder catheter inserted during their ablation procedure.
Intervention: No catheter
Device: No catheter
Subjects will not receive a bladder catheter during the ablation procedure
Active Comparator: Bladder catheter inserted
Bladder catheter will be inserted prior to starting ablation procedure after the subject is under general anesthesia.
Intervention: bladder catheter inserted
Device: Insert bladder catheter
Bladder catheter will be inserted according to randomization schema
- Composite of catheter associated complications at day one and thirty will be assessed among the two arms - those with bladder catheters and those who did not receive the bladder catheter during the ablation procedure. [ Time Frame: Post-op day 1 and 30 days ]Per patient reported outcomes, subjects will be asked if they experienced any of the following complications: cystitis, hematuria, dysuria, urethral damage and urinary retention. The primary composite outcome of cystitis, hematuria, dysuria, urethral damage or urinary retention will be compared using Chisq or Fisher's exact test. Additional bivariate correlates to the primary outcome will be analysed including age, gender, operator, procedure satisfaction score, procedure duration, procedural fluid administration, total hospital stay fluid administration, and baseline clinical variables. Variables with p value <o.o5 on bivariate analysis will be included in a multivariate regression model.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635034
|Contact: Parin Patel, MD||317-338-6666||Parin.firstname.lastname@example.org|
|Contact: Melanie Glover, BSN, MBA||317-338-8042||Melanie.email@example.com|
|United States, Indiana|
|St. Vincent Hospital and Healthcare Center||Recruiting|
|Indianapolis, Indiana, United States, 46260|
|Contact: Exec. Director, CV Research 317-338-8042 Melanie.firstname.lastname@example.org|
|Principal Investigator: Parin Patel, MD|