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)
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2017
CompletedStudy Start
First participant enrolled
June 6, 2017
CompletedFirst Posted
Study publicly available on registry
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2020
CompletedFebruary 21, 2021
February 1, 2021
3.6 years
May 9, 2017
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Prevalence of in hospital brady arrhythmia post TAVR
72 hours post TAVR
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
Interventions
Ziopatch applied 2 weeks prior to procedure
Ziopatch applied at discharge from hospital to be worn for 2 weeks
Ziopatch applied 2 months from procedure to be worn for 2 weeks
Eligibility Criteria
Patients to be scheduled for TAVR without preexisting Cardiac Implantable Electronic Device (CIED) can be screen and enrolled
You may qualify if:
- Age \> 18 and \<90 years old
- Able to provide informed consent
- Willing to follow up at Cleveland Clinic (per TAVR protocol)
You may not qualify if:
- Prior CIED (Pacemaker or defibrillator)
- Unable to provide consent
- Unable to follow up at Cleveland Clinic per TAVR protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
Tarakji KG, Patel D, Krishnaswamy A, Hussein A, Saliba W, Wilkoff BL, Wolski K, Svensson L, Wazni OM, Kapadia SR. Bradyarrhythmias detected by extended rhythm recording in patients undergoing transcatheter aortic valve replacement (Brady-TAVR Study). Heart Rhythm. 2022 Mar;19(3):381-388. doi: 10.1016/j.hrthm.2021.11.020. Epub 2021 Nov 18.
PMID: 34801735DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khaldoun Tarakji, MD
The Cleveland Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2017
First Posted
June 8, 2017
Study Start
June 6, 2017
Primary Completion
December 23, 2020
Study Completion
December 23, 2020
Last Updated
February 21, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share