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

NCT ID: NCT03180073

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-06

Study Completion Date

2020-12-23

Brief Summary

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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.

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Detailed Description

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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

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Bradycardia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Ziopatch Pre discharge

Ziopatch applied 2 weeks prior to procedure

Intervention Type DIAGNOSTIC_TEST

Ziopatch at Discharge

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

Intervention Type DIAGNOSTIC_TEST

Ziopatch at 2 months

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Khaldoun Tarakji

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khaldoun Tarakji, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34801735 (View on PubMed)

Other Identifiers

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17-086

Identifier Type: -

Identifier Source: org_study_id

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