Accelerometer Sensing for Micra AV Study

  • STATUS
    Recruiting
  • participants needed
    175
  • sponsor
    Medtronic Cardiac Rhythm and Heart Failure
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Updated on 19 February 2024
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atrioventricular block

Summary

The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.

Description

The Accel AV study is a prospective, single-arm, global, multi-center clinical study to characterize the chronic AV synchrony in subjects implanted with the market released Micra AV system. The study is planned to be conducted in the US and Hong Kong. Overall, the study is expected to be conducted at approximately 20 centers.The expected total study duration is approximately 12-15 months, representing the time necessary to enroll the target sample size and to complete the 3-month follow-up visit.

Details
Condition Atrioventricular Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
Age 18years - 100years
Treatment Accelerometer Sensing for Micra AV Study
Clinical Study IdentifierNCT04245345
SponsorMedtronic Cardiac Rhythm and Heart Failure
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subject will be implanted with a MicraTM (Model MC1AVR1) for an approved
indication
Subject has history of AV block
Subject is 18 years old and as per required local law
Subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements
Subject is willing and able to comply with the protocol

Exclusion Criteria

Subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Clinical Research Specialist
Subject implanted with a MicraTM (Model MC1AVR1) on a non-permanent basis (e.g. CIED infection)
Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MicraTM Model MC1AVR1 implant procedures)
Subject meets any exclusion criteria required by local law (age or other)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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