NCT03180073

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bradycardia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ziopatch Pre discharge	Ziopatch applied 2 weeks prior to procedure
DIAGNOSTIC_TEST	Ziopatch at Discharge	Ziopatch applied at discharge from hospital to be worn for 2 weeks
DIAGNOSTIC_TEST	Ziopatch at 2 months	Ziopatch applied 2 months from procedure to be worn for 2 weeks

Timeline

• Start date: 2017-06-06
• Primary completion: 2020-12-23
• Completion: 2020-12-23
• First posted: 2017-06-08
• Last updated: 2021-02-21

Locations

1 site across 1 country: United States