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OpenTrials
Completed

NCT Number: NCT03180073

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

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ziopatch Pre discharge

Diagnostic Test

Ziopatch applied 2 weeks prior to procedure

Ziopatch at Discharge

Diagnostic Test

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

Ziopatch at 2 months

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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. 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)

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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)

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2017
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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