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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bradycardia
- Sponsor
- The Cleveland Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Need for Pacemaker post TAVR
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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
Investigators
Khaldoun Tarakji
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Prevalence of brady arrhythmia after discharge from hospital post TAVR(3 weeks post discharge)
- Prevalence of delayed brady arrhythmia post TAVR(2 months post TAVR)
- Prevalence of in hospital brady arrhythmia post TAVR(72 hours post TAVR)