Micra AV Transcatheter Pacing System Post-Approval Registry
- Conditions
- Bradycardia
- Registration Number
- NCT04253184
- Lead Sponsor
- Medtronic
- Brief Summary
Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release.
The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.
- Detailed Description
The Micra AV Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra AV Registry will be prospectively followed for a minimum of 3 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent).
Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra AV system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's routine clinical care practice, those visits are reported. The total estimated registry duration is 4.5 years
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 802
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient is intended to receive or be treated with a Micra AV Transcatheter Pacing System and must be enrolled prior to the implant procedure
- Patient who is, or is expected to be inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of pacemaker syndrome After 3 years of Follow Up To characterize the rate of pacemaker syndrome resulting in a system revision at 3-years post-implant.
- Secondary Outcome Measures
Name Time Method Acute complication rate After 30 days of Follow Up To estimate the acute major complication rate related to the Micra AV system and/or procedure.
Long-term complication rate After 3 years of Follow up To estimate the 3-year major complication rate related to the Micra AV system and/or procedure.
Trial Locations
- Locations (89)
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Eisenhower Desert Cardiology Center
🇺🇸Rancho Mirage, California, United States
Sequoia Hospital
🇺🇸Redwood City, California, United States
Yale New Haven Health System
🇺🇸New Haven, Connecticut, United States
Baptist Health
🇺🇸Jacksonville, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Indiana University Health Methodist Research Institute
🇺🇸Indianapolis, Indiana, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
University of Kansas Medical Center Research Institute
🇺🇸Kansas City, Kansas, United States
Saint Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
Scroll for more (79 remaining)The University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States