N/A
Completed N=276
Micra Transcatheter Pacing System Continued Access Study Protocol
Bradycardia
Source: ClinicalTrials.gov NCT02488681 ↗
Enrolled (actual)
276
Serious AEs
9.8%
Results posted
Jan 2018
Primary outcomePrimary: Complications — 4 % participants with complication
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complications |
4 | — |
Eligibility Criteria
Inclusion Criteria
- Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Subject meets Class I or ll indication for implantation of single chamber ventricular pacemaker and is intended to be implanted with a Micra System
- Subject able and accessible for follow-up per study requirements
- Subject is at least 18 years of age
- Patient is not enrolled in a concurrent drug and/or device study that may confound registry result.
Exclusion Criteria
- Subject has had an acute myocardial infraction (AMI) within 30 days of implant
- Subject has implantation of neurostimulator or any other chronically implanted device which uses current in the body
- Subject with mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD)
- Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head.
- Subject who 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 sever tortuosity) in the opinion of the implanter
- Subjects with known intolerance to Nickel-Titanium (Nitinol) Alloy
- Subject for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated
- Subjects with life expectancy less than 12-months
- Subject is enrolled in a concurrent drug and/or device study that may confound CA study results
Data sourced from ClinicalTrials.gov (NCT02488681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.