Clinical trial NCT04489095: Conduction Disease After Transcatheter Aortic Valve Replacement
Official title: Evaluation of Conduction Disease After Trans-catheter Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Heart Block
Aortic Insufficiency
Keywords: Transcatheter Aortic Valve Replacement
TAVR
Aortic stenosis
AS
Pacemaker
HV interval
Electrophysiology Study
EPS
Heart block
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2020-07-28
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: After informed consent is obtained, patient will undergo TAVR as per usual standard of care. Using the same femoral vein access as is used standard for a portion of the TAVR procedure, an EPS(Electrophysiology study) will be performed during the TAVR procedure, immediately before and after valve implantation. The patient will recover on a general telemetry floor as per usual care, and the next day will undergo another EPS. This is not uncommonly done clinically for some patients after TAVR. At that point, based on the baseline EKG, intra-procedure findings, and EPS findings, the patient will either have a pacemaker implanted, a 30-day event monitor ordered, or neither of the above.
Primary purpose: DIAGNOSTIC

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 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.

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.

Primary outcomes:
measure: High grade conduction disease post TAVR
timeFrame: 1 year
Secondary outcomes:
measure: death
timeFrame: 1 year
measure: rehospitalization
timeFrame: 1 year
measure: need for pacemaker implantation
timeFrame: 1 year
measure: HV interval pre and post TAVR
timeFrame: 2 days
measure: ejection fraction
timeFrame: 1 year
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Tiberio Frisoli, MD
role: PRINCIPAL_INVESTIGATOR
References: