NCT03635034

Bladder Catheters During Ablation Procedures

Completed NA Last updated 30 September 2021

What this trial tests

NA trial testing Insert bladder catheter in Atrial Fibrillation in 160 participants. Completed in 16 January 2020.

Timeline

16 January 2018

Primary endpoint
16 January 2020

16 January 2020

Quick facts

Lead sponsor	St. Vincent Cardiovascular Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	160
Start date	16 January 2018
Primary completion	16 January 2020
Estimated completion	16 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Insert bladder catheter
• No catheter

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Catheter Ablation — all drugs for Catheter Ablation →
• Catheter Complications — all drugs for Catheter Complications →

Sponsor

St. Vincent Cardiovascular Research Institute

Who can join

18 and older, any sex, with Atrial Fibrillation or Catheter Ablation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Avoiding Urinary Catheterization in Patients Undergoing Atrial Fibrillation Catheter Ablation.
   Lehman AB, Ahmed AS, Patel PJ. · · 2019 · cited 3× · PMID 32435346 · DOI 10.4022/jafib.2221