Bladder Catheters During Ablation Procedures

NCT03635034 | Completed FDA Device

• 1 other identifier: R20180053
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Catheter Ablation; Catheter Complications

Keywords

urinary catheter; catheter ablation procedures

Outcome Measures

Primary Outcomes (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.

  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.

  Post-op day 1 and 30 days

Study Arms (2)

No Bladder catheter

EXPERIMENTAL

Subjects will not have bladder catheter inserted during their ablation procedure. Intervention: No catheter

Device: No catheter

Bladder catheter inserted

ACTIVE COMPARATOR

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

Interventions

Insert bladder catheter DEVICE

Bladder catheter will be inserted according to randomization schema

Bladder catheter inserted

No catheter DEVICE

Subjects will not receive a bladder catheter during the ablation procedure

No Bladder catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Vincent Cardiovascular Research Institute: lead

Study Sites (1)

St. Vincent Hospital and Healthcare Center

Indianapolis, Indiana, 46260, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 17, 2018
• Study Start: January 16, 2018
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

US (1)