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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
Sponsor:
Information provided by (Responsible Party):
St. Vincent Cardiovascular Research Institute

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Catheter Ablation Catheter Complications Device: Insert bladder catheter Device: No catheter Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635034


Contacts
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Contact: Parin Patel, MD 317-338-6666 Parin.patel@ascension.org
Contact: Melanie Glover, BSN, MBA 317-338-8042 Melanie.glover@ascension.org

Locations
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United States, Indiana
St. Vincent Hospital and Healthcare Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Exec. Director, CV Research    317-338-8042    Melanie.glover@ascension.org   
Principal Investigator: Parin Patel, MD         
Sponsors and Collaborators
St. Vincent Cardiovascular Research Institute

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Responsible Party: St. Vincent Cardiovascular Research Institute
ClinicalTrials.gov Identifier: NCT03635034     History of Changes
Other Study ID Numbers: R20180053
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by St. Vincent Cardiovascular Research Institute:
urinary catheter
catheter ablation procedures
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes