Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
157 participants
INTERVENTIONAL
2020-06-09
2022-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single-arm
Subjects implanted with the Medtronic Micra AV device
Accelerometer Sensing for Micra AV Study
Characterize AV synchrony in subjects implanted with Micra AV device. The study will be conducted upon market approval of the Micra AV Transcatheter Pacing System.
Interventions
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Accelerometer Sensing for Micra AV Study
Characterize AV synchrony in subjects implanted with Micra AV device. The study will be conducted upon market approval of the Micra AV Transcatheter Pacing System.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Larry Chinitz, MD
Role: STUDY_CHAIR
NYU Langone
Locations
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Saint Joseph's Medical Center
Stockton, California, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Citrus Cardiology Consultants PA
Leesburg, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Northwell Health
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
Duke University Nedical Center
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Mount Carmel Health System
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Centennial Heart Cardiovascular Consultants
Nashville, Tennessee, United States
Baylor Research Institute
Plano, Texas, United States
Multicare Institute for Research and Innovation
Tacoma, Washington, United States
University of Wisconsin (UW) Hospital and Clinics
Madison, Wisconsin, United States
Queen Mary Hospital
Hong Kong, HK, Hong Kong
Prince of Wales Hospital
Shatin, HK, Hong Kong
Countries
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References
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Chinitz LA, El-Chami MF, Sagi V, Garcia H, Hackett FK, Leal M, Whalen P, Henrikson CA, Greenspon AJ, Sheldon T, Stromberg K, Wood N, Fagan DH, Sun Chan JY. Ambulatory atrioventricular synchronous pacing over time using a leadless ventricular pacemaker: Primary results from the AccelAV study. Heart Rhythm. 2023 Jan;20(1):46-54. doi: 10.1016/j.hrthm.2022.08.033. Epub 2022 Sep 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AccelAV
Identifier Type: -
Identifier Source: org_study_id
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