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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03180073
Recruitment Status : Active, not recruiting
First Posted : June 8, 2017
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Khaldoun Tarakji, The Cleveland Clinic

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.

Condition or disease Intervention/treatment
Bradycardia Diagnostic Test: Ziopatch Pre discharge Diagnostic Test: Ziopatch at Discharge Diagnostic Test: Ziopatch at 2 months

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia


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


Primary Outcome Measures :
  1. Need for Pacemaker post TAVR [ Time Frame: 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 Outcome Measures :
  1. Prevalence of in hospital brady arrhythmia post TAVR [ Time Frame: 72 hours post TAVR ]
    the prevalence of brady arrhythmia (Sinus brady, Sinus pause, AV block, Bundle branch block) using hospital telemetry data

  2. Prevalence of brady arrhythmia after discharge from hospital post TAVR [ Time Frame: 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)

  3. Prevalence of delayed brady arrhythmia post TAVR [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients to be scheduled for TAVR without preexisting Cardiac Implantable Electronic Device (CIED) can be screen and enrolled
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180073


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Khaldoun Tarakji, MD The Cleveland Clinic
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Responsible Party: Khaldoun Tarakji, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03180073    
Other Study ID Numbers: 17-086
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Bradycardia
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Arrhythmias, Cardiac
Pathologic Processes