Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04489095 |
| Other study ID # |
Frisoli_13944 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 16, 2020 |
| Est. completion date |
August 1, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
Henry Ford Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a prospective single center Cardiology department observational study. The study aim
is to better understand the predictors of high grade conduction abnormalities associated with
TAVR such that a more robust evidence-based and universal strategy to manage cardiac
conduction disturbances in these patients, which has been elusive, can be developed.
Description:
TAVR is a very commonly performed procedure throughout the world; it has become standard of
care as the treatment for aortic stenosis and is performed in hundreds of thousands of
patients annually. TAVR affords patients therapies that prolong life and improve quality of
life; furthermore, these therapies afford certain patients who are not candidates for
surgical options hope for the future. Adults undergoing TAVR may suffer the complication of
requiring a pacemaker after the procedure, in up to 30% of cases. Interventionalists still
don't understand how to best predict this complication; in fact some patients that ultimately
need a pacemaker don't get one after the procedure and some that get a pacemaker are found to
ultimately not have really needed it. A better understanding of which patients do and do not
need pacemakers will help prevent complications of high grade block in those without
pacemaker (death, syncope and trauma) and also the complications of unnecessary pacemaker
implantation (infection, tricuspid regurgitation).
Primary hypothesis: EP studies (EPS), when performed before and after TAVR adds independent
incremental value, above and beyond other parameters, for the prediction of high-grade heart
block after TAVR. The goal is to understand conduction disease changes before and after TAVR,
coupled with other patient and procedural factors that can help create a management algorithm
for conduction disease after TAVR.
Primary endpoint: to find correlation coefficients between a) absolute and delta values of
various EPS findings, and b) clinical endpoint of high-grade conduction disease as diagnosed
clinically, by ECG, by event monitor, or by interrogation of permanent pacemaker implanted
after TAVR.
Methods: Patients will receive EPS immediately before and after TAVR (while on the
catheterization lab table for TAVR procedure) and then again the next day; this information
will help determine whether the patient gets a pacemaker, a 30-day event monitor, or neither.
The investigators will study which parameters obtained during the EPS, in addition to other
known/suspected predictors of conduction disease after TAVR, best correlate with serious
problems with the heart's electrical conduction system as determined by clinical follow-up.
Anticipated findings: that the EPS findings add incremental and independent value in
predicting which patients will develop high grade conduction disease.
