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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients to be scheduled for TAVR without preexisting Cardiac Implantable Electronic Device (CIED) can be screen and enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Khaldoun Tarakji, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34801735 | Derived | Tarakji KG, Patel D, Krishnaswamy A, Hussein A, Saliba W, Wilkoff BL, Wolski K, Svensson L, Wazni OM, Kapadia SR. Bradyarrhythmias detected by extended rhythm recording in patients undergoing transcatheter aortic valve replacement (Brady-TAVR Study). Heart Rhythm. 2022 Mar;19(3):381-388. doi: 10.1016/j.hrthm.2021.11.020. Epub 2021 Nov 18. |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |