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

Bradycardia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180073
• Other study ID #: 17-086
• Status: Completed
• Start date: June 6, 2017
• Est. completion date: December 23, 2020

Study information

• Verified date: February 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 23, 2020
• Est. primary completion date: December 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Bradycardia

Intervention

Diagnostic Test:
• Ziopatch Pre discharge
Ziopatch applied 2 weeks prior to procedure
• Ziopatch at Discharge
Ziopatch applied at discharge from hospital to be worn for 2 weeks
• Ziopatch at 2 months
Ziopatch applied 2 months from procedure to be worn for 2 weeks

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Prevalence of brady arrhythmia after discharge from hospital post TAVR	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
Secondary	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