Accelerometer Sensing for Micra AV Study

Completed · Not applicable

Conditions studied: AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block

In brief

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.

Key facts

Study ID

NCT04245345

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

157

Starts

2020-06-09

Expected to finish

2022-01-10

Last updated by the study team

2023-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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