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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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date August 1, 2022
Est. primary completion date February 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
Electrophysiology Study
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 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.

Locations

Country Name City State
United States Henry Ford Health System Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
Henry Ford Health System Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary High grade conduction disease post TAVR Number of participants that develop high grade conduction block post TAVR including complete heart block, 2nd degree AV block, symptomatic bradycardia 1 year
Secondary death Rate of mortality by chart review and SSDI query at 1 year 1 year
Secondary rehospitalization Absolute and per patient hospitalizations post index procedure 1 year
Secondary need for pacemaker implantation Percentage of participants requiring permanent pacemaker implantation in index hospitalization or within 1 year 1 year
Secondary HV interval pre and post TAVR Absolute HV interval in milliseconds as measure by electrophysiology study for each participant pre and post TAVR 2 days
Secondary ejection fraction Ejection fraction as measured by trans-thoracic echocardiography for each participant pre and post tavr on routine trans-thoracic echocardiography 1 year
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