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

The Cleveland Clinic100 enrolled

Overview

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.

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

100

Conditions

Bradycardia

Interventions

Ziopatch Pre dischargeDIAGNOSTIC_TEST

Ziopatch applied 2 weeks prior to procedure

Ziopatch at DischargeDIAGNOSTIC_TEST

Ziopatch applied at discharge from hospital to be worn for 2 weeks

Ziopatch at 2 monthsDIAGNOSTIC_TEST

Ziopatch applied 2 months from procedure to be worn for 2 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 months prior to TAVR

Secondary Outcomes

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

Time frame: 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)

Time frame: 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)

Time frame: 2 months post TAVR

Data from ClinicalTrials.gov

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