Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03635034 |
Other study ID # |
R20180053 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 16, 2018 |
Est. completion date |
January 16, 2020 |
Study information
Verified date |
September 2021 |
Source |
St. Vincent Cardiovascular Research Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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