Bladder Catheters During Ablation Procedures
Primary Purpose
Atrial Fibrillation, Catheter Ablation, Catheter Complications
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insert bladder catheter
No catheter
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation focused on measuring urinary catheter, catheter ablation procedures
Eligibility Criteria
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.
Sites / Locations
- St. Vincent Hospital and Healthcare Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
No Bladder catheter
Bladder catheter inserted
Arm Description
Subjects will not have bladder catheter inserted during their ablation procedure. Intervention: No catheter
Bladder catheter will be inserted prior to starting ablation procedure after the subject is under general anesthesia. Intervention: bladder catheter inserted
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03635034
First Posted
July 27, 2018
Last Updated
September 29, 2021
Sponsor
St. Vincent Cardiovascular Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03635034
Brief Title
Bladder Catheters During Ablation Procedures
Official Title
Examining the Routine Use of Bladder Catheters During Atrial Fibrillation Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
January 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Vincent Cardiovascular Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Catheter Ablation, Catheter Complications
Keywords
urinary catheter, catheter ablation procedures
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will compare the two groups for complications related to catheter or not having a catheter placed.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Bladder catheter
Arm Type
Experimental
Arm Description
Subjects will not have bladder catheter inserted during their ablation procedure.
Intervention: No catheter
Arm Title
Bladder catheter inserted
Arm Type
Active Comparator
Arm Description
Bladder catheter will be inserted prior to starting ablation procedure after the subject is under general anesthesia.
Intervention: bladder catheter inserted
Intervention Type
Device
Intervention Name(s)
Insert bladder catheter
Intervention Description
Bladder catheter will be inserted according to randomization schema
Intervention Type
Device
Intervention Name(s)
No catheter
Intervention Description
Subjects will not receive a bladder catheter during the ablation procedure
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Post-op day 1 and 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
St. Vincent Hospital and Healthcare Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
12. IPD Sharing Statement
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Bladder Catheters During Ablation Procedures
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