Brief Title
Conduction Disease After Transcatheter Aortic Valve Replacement
Official Title
Evaluation of Conduction Disease After Trans-catheter Aortic Valve Replacement
Brief 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.
Detailed 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 who does and who does 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), which studies 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,
and we 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.
Study Type
Interventional
Primary Outcome
High grade conduction disease post TAVR
Secondary Outcome
death
Condition
Aortic Stenosis
Intervention
Electrophysiology Study
Study Arms / Comparison Groups
Electrophysiology Study pre and Post TAVR
Description: In all patient's undergoing TAVR after informed consent will undergo an electrophysiology study pre and post device deployment in order to determine the need for permanent pacemaker implantation or further testing/monitoring.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
200
Start Date
July 2020
Completion Date
June 1, 2022
Primary Completion Date
June 1, 2021
Eligibility Criteria
Inclusion Criteria
- Signed and dated Informed Consent
- Patient that undergoes a TAVR
- Ability to complete functional assessments.
Exclusion Criteria:
- Patients with pre-existing permanent pacemaker.
- Patient unwilling or unable to follow-up for necessary pre- and post-procedure
clinical assessments.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Tiberio Frisoli, MD, 313-850-7336, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04489095
Organization ID
Frisoli_13944
Responsible Party
Principal Investigator
Study Sponsor
Henry Ford Health System
Collaborators
Medtronic
Study Sponsor
Tiberio Frisoli, MD, Principal Investigator, Henry Ford Health System
Verification Date
July 2020