A Study for the Continued Access of the Micra Transcatheter Pacing System
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004430
NCT ID: NCT02488681
Sponsor Protocol Number: Micra CA
About this study
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Written authorization and/or consent per institution and geographical requirements
- Class I or ll indication for implantation of single chamber ventricular pacemaker and is intended to be implanted with a Micra System
- Able and accessible for follow-up per study requirements
- At least 18 years of age
- Not enrolled in a concurrent drug and/or device study that may confound registry result
Exclusion Criteria
- Has had an acute myocardial infraction (AMI) within 30 days of implant
- Has implantation of neurostimulator or any other chronically implanted device which uses current in the body
- Has mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD)
- Is morbidly obese and physician believes telemetry communication of ≤ 5 inches (12.5 cm) could not be obtained with programmer head.
- Femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example due to obstructions or severe tortuosity) in the opinion of the implanter
- Has known intolerance to Nickel-Titanium (Nitinol) Alloy
- A single dose of 1.0mg dexamethasone acetate may be contraindicated
- Life expectancy less than 12 months
- Enrolled in a concurrent drug and/or device study that may confound CA study results
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Yong-Mei Cha, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available