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

NeuroTherapia, Inc.

Status: Completed

Conditions: Bradycardia

Treatments: Diagnostic Test: Ziopatch Pre discharge; Diagnostic Test: Ziopatch at Discharge; Diagnostic Test: Ziopatch at 2 months

Study type: Observational

Funder types: Other

Identifiers

NCT03180073

17-086

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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