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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03180073

Enrollment

100

Registered

2017-06-08

Start date

2017-06-06

Completion date

2020-12-23

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia

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

Interventions

DIAGNOSTIC_TESTZiopatch Pre discharge

Ziopatch applied 2 weeks prior to procedure

DIAGNOSTIC_TESTZiopatch at Discharge

Ziopatch applied at discharge from hospital to be worn for 2 weeks

DIAGNOSTIC_TESTZiopatch at 2 months

Ziopatch applied 2 months from procedure to be worn for 2 weeks

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Need for Pacemaker post TAVR	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

Measure	Time frame	Description
Prevalence of in hospital brady arrhythmia post TAVR	72 hours post TAVR	the prevalence of brady arrhythmia (Sinus brady, Sinus pause, AV block, Bundle branch block) using hospital telemetry data
Prevalence of brady arrhythmia after discharge from hospital post TAVR	3 weeks post discharge	the prevalence of brady arrhythmia (Sinus brady, Sinus pauses, AV block, Bundle branch block) using extended cardiac rhythm monitor (Zio Patch)
Prevalence of delayed brady arrhythmia post TAVR	2 months 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026