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



Status:Active, not recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 90
Updated:3/6/2019
Start Date:June 6, 2017
End Date:January 30, 2020

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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

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
We found this trial at
1
site
Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-445-9225
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