Accelerometer Sensing for Micra AV Study

Last updated: February 21, 2023
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Overall Status: Completed

Phase

N/A

Condition

Arrhythmia

Cardiac Disease

Heart Defect

Treatment

N/A

Clinical Study ID

NCT04245345
AccelAV
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 datedauthorization and/or consent per institution and local requirements.
  • Subject is willing and able to comply with the protocol.

Exclusion

Exclusion Criteria:

  • Subject currently enrolled or planning to participate in a potentially confoundingdrug or device trial during the study. Co-enrollment in concurrent trials is onlyallowed when documented pre-approval is obtained from the Medtronic Clinical ResearchSpecialist.
  • Subject implanted with a MicraTM (Model MC1AVR1) on a non-permanent basis (e.g. CIEDinfection).
  • Subject is pregnant (if required by local law, women of child-bearing potential mustundergo a pregnancy test within seven days prior to MicraTM Model MC1AVR1 implantprocedures).
  • Subject meets any exclusion criteria required by local law (age or other).

Study Design

Total Participants: 157
Study Start date:
June 09, 2020
Estimated Completion Date:
January 10, 2022

Study 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.

Connect with a study center

  • Queen Mary Hospital

    Hong Kong, HK
    Hong Kong

    Site Not Available

  • Prince of Wales Hospital

    Sha Tin, HK
    Hong Kong

    Site Not Available

  • Saint Joseph's Medical Center

    Stockton, California 95204
    United States

    Site Not Available

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Citrus Cardiology Consultants PA

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Catholic Medical Center

    Manchester, New Hampshire 03102
    United States

    Site Not Available

  • Northwell Health

    Manhasset, New York 11030
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Duke University Nedical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Mount Carmel Health System

    Columbus, Ohio 43213
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Centennial Heart Cardiovascular Consultants

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Baylor Research Institute

    Plano, Texas 75093
    United States

    Site Not Available

  • Multicare Institute for Research and Innovation

    Tacoma, Washington 98405
    United States

    Site Not Available

  • University of Wisconsin (UW) Hospital and Clinics

    Madison, Wisconsin 53792
    United States

    Site Not Available

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