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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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)

Conditions
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Bradycardia

Intervention / Treatment
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* Diagnostic Test: Ziopatch Pre discharge
* Diagnostic Test: Ziopatch at Discharge
* Diagnostic Test: Ziopatch at 2 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 and <90 years old Able to provide informed consent Willing to follow up at Cleveland Clinic (per TAVR protocol) Exclusion Criteria: Prior CIED (Pacemaker or defibrillator) Unable to provide consent Unable to follow up at Cleveland Clinic per TAVR protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ziopatch Pre discharge|Ziopatch applied 2 weeks prior to procedure|
|Diagnostic Test: Ziopatch at Discharge|Ziopatch applied at discharge from hospital to be worn for 2 weeks|
|Diagnostic Test: Ziopatch at 2 months|Ziopatch applied 2 months from procedure to be worn for 2 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Pacemaker post 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 | 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 | 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 | 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 |