Conduction Disease After Transcatheter Aortic Valve Replacement

NCT04489095 | Completed FDA Device

• 1 other identifier: Frisoli_13944
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis; Heart Block; Aortic Insufficiency

Keywords

Transcatheter Aortic Valve Replacement; TAVR; Aortic stenosis; AS; Pacemaker; HV interval; Electrophysiology Study; EPS; Heart block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• death

  1 year

• rehospitalization

  1 year

• need for pacemaker implantation

  1 year

• HV interval pre and post TAVR

  2 days

• ejection fraction

  1 year

Study Arms (1)

Electrophysiology Study pre and Post TAVR

EXPERIMENTAL

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

Interventions

Electrophysiology Study DIAGNOSTIC_TEST

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.

Electrophysiology Study pre and Post TAVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated Informed Consent
• Patient that undergoes a TAVR
• Ability to complete functional assessments.

You may not qualify if:

• Patients with pre-existing permanent pacemaker.
• Patient unwilling or unable to follow-up for necessary pre- and post-procedure clinical assessments.

Sponsors & Collaborators

• Henry Ford Health System: lead
• Medtronic: collaborator

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Block; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiberio Frisoli, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: July 28, 2020
• Study Start: July 16, 2020
• Primary Completion: February 17, 2022
• Study Completion: August 1, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)