Conduction Disease After Transcatheter Aortic Valve Replacement

Evaluation of Conduction Disease After Trans-catheter Aortic Valve Replacement

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis; Heart Block; Aortic Insufficiency
• Intervention / Treatment: Diagnostic test: Electrophysiology Study

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Electrophysiology Study pre and Post TAVR; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
death	Rate of mortality by chart review and SSDI query at 1 year	1 year
rehospitalization	Absolute and per patient hospitalizations post index procedure	1 year
need for pacemaker implantation	Percentage of participants requiring permanent pacemaker implantation in index hospitalization or within 1 year	1 year
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
ejection fraction	Ejection fraction as measured by trans-thoracic echocardiography for each participant pre and post tavr on routine trans-thoracic echocardiography	1 year

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Medtronic
• Investigators: Principal Investigator: Tiberio Frisoli, MD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2020
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement; Aortic stenosis; Pacemaker; TAVR; AS; Electrophysiology Study; Heart block; HV interval; EPS
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Cardiac Conduction System Disease; Aortic Valve Stenosis; Heart Block; Aortic Valve Insufficiency
• Other Study ID Numbers: Frisoli_13944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes