Accelerometer Sensing for Micra AV Study
Status: Completed
Location: See all (20) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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.
Locations
United States
California
Saint Joseph's Medical Center
Stockton
Florida
Baptist Medical Center Jacksonville
Jacksonville
Citrus Cardiology Consultants PA
Leesburg
Georgia
Emory University Hospital
Atlanta
North Carolina
Duke University Nedical Center
Durham
Wake Forest Baptist Medical Center
Winston-salem
New Hampshire
Catholic Medical Center
Manchester
New York
Northwell Health
Manhasset
NYU Langone Medical Center
New York
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Mount Carmel Health System
Columbus
The Ohio State University Wexner Medical Center
Columbus
Oregon
Oregon Health & Science University
Portland
Pennsylvania
Thomas Jefferson University
Philadelphia
Tennessee
Centennial Heart Cardiovascular Consultants
Nashville
Texas
Baylor Research Institute
Plano
Washington
Multicare Institute for Research and Innovation
Tacoma
Wisconsin
University of Wisconsin (UW) Hospital and Clinics
Madison
Other Locations
Hong Kong Special Administrative Region
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Sha Tin
Time Frame
Start Date: 2020-06-09
Completion Date: 2022-01-10
Participants
Target number of participants: 157
Treatments
Other: Single-arm
Subjects implanted with the Medtronic Micra AV device
Authors
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiac Rhythm and Heart Failure