Conduction Abnormalities With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement

February 17, 2021 updated by: Khaldoun Tarakji, The Cleveland Clinic

Prevalence and Significance of Bradycardic Arrhythmias and Conduction Abnormalities Among Patients With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement Using Extended Heart Rhythm Recording (Brady-TAVR Study)

Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation. Little is known about the prevalence and timing of any conduction abnormalities that exist before (other than standard ECG) or after through long term cardiac monitoring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each subject who fulfills the inclusion/exclusion criteria will be provided with Zio patch for 2 weeks before TAVR. Immediately after the procedure, patients will be admitted per TAVR protocol and will be on telemetry. Data about their ECGs and any arrhythmias will be collected.

Upon discharge, patients will be provided with another Zio patch for 2 weeks. At the 2-3 months follow up, subjects will be provided with a third Zio patch for 2 weeks

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients to be scheduled for TAVR without preexisting Cardiac Implantable Electronic Device (CIED) can be screen and enrolled

Description

Inclusion Criteria:

  1. Age > 18 and <90 years old
  2. Able to provide informed consent
  3. Willing to follow up at Cleveland Clinic (per TAVR protocol)

Exclusion Criteria:

  1. Prior CIED (Pacemaker or defibrillator)
  2. Unable to provide consent
  3. Unable to follow up at Cleveland Clinic per TAVR protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for Pacemaker post TAVR
Time Frame: 2 months prior to TAVR
the prevalence of brady arrhythmia (Sinus brady, Sinus Pauses, AV Block, Bundle Branch Block) among patients with severe aortic stenosis who undergo TAVR using an extended cardiac rhythm monitor (Zio Patch) and determine if the brady arrhythmias predict the need for a pacemaker.
2 months prior to TAVR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of in hospital brady arrhythmia post TAVR
Time Frame: 72 hours post TAVR
the prevalence of brady arrhythmia (Sinus brady, Sinus pause, AV block, Bundle branch block) using hospital telemetry data
72 hours post TAVR
Prevalence of brady arrhythmia after discharge from hospital post TAVR
Time Frame: 3 weeks post discharge
the prevalence of brady arrhythmia (Sinus brady, Sinus pauses, AV block, Bundle branch block) using extended cardiac rhythm monitor (Zio Patch)
3 weeks post discharge
Prevalence of delayed brady arrhythmia post TAVR
Time Frame: 2 months post TAVR
the prevalence of brady arrhythmia using extended cardiac rhythm Assess the prevalence of brady arrhythmia (Sinus brady, Sinus Pause, AV block, Bundle branch block) using extended cardiac rhythm monitor (Zio Patch)
2 months post TAVR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Khaldoun Tarakji, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2017

Primary Completion (Actual)

December 23, 2020

Study Completion (Actual)

December 23, 2020

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-086

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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