An interventional study of Micra Pacemaker Implant in Bradycardia, sponsored by Medtronic. Completed at 29 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by Medtronic · Not applicable, Interventional, and Treatment
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).
The Micra CA study is a prospective, non-randomized, multi-center, study designed to allow controlled access of the Micra system when used as intended. All subjects enrolled in the Micra CA Study will be prospectively followed from implant, at 6-month intervals until study closure (i.e. FDA approval). Patients with previous or existing inactive implanted cardiac stimulation systems will have additional follow ups.
306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.
This study's enrollment of 285 is above the median of 99 across 174 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →Medtronic is the lead sponsor of 42 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Micra Pacemaker Implant
Device: Micra Pacemaker Implant
Complications
Micra system and/or procedure-related complication rate
Time frame: 3 months post last follow up
A total of 285 subjects were consented at 31 research centers in the United States from June 2015 to April 2016 when FDA approval was obtained.
| Milestone | Micra Pacemaker Implant |
|---|---|
| Started | 276 |
| Completed | 269 |
| Not completed | 7 |
| Withdrew: Implant unsuccessful | 7 |
Micra system and/or procedure-related complication rate
| % participants with complication | Micra Pacemaker Implant |
|---|---|
| Complications | 4 (2 to 7) |
Collected over From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Micra Pacemaker Implant | — | 27/276 (9.8%) | 16/276 (5.8%) |
| Event | Micra Pacemaker Implant |
|---|---|
| Incision site haemorrhageInjury, poisoning and procedural complications | 3/276 |
| Atrioventricular block completeCardiac disorders | 2/276 |
| Cardiac perforationCardiac disorders | 2/276 |
| Pericardial effusionCardiac disorders | 2/276 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 2/276 |
| Cardio-respiratory arrestCardiac disorders | 1/276 |
| Cardiogenic shockCardiac disorders | 1/276 |
| Myocardial infarctionCardiac disorders | 1/276 |
| Supraventricular tachycardiaCardiac disorders | 1/276 |
| Adverse drug reactionGeneral disorders | 1/276 |
| Event | Micra Pacemaker Implant |
|---|---|
| Device pacing issueGeneral disorders | 4/276 |
| Incision site haematomaInjury, poisoning and procedural complications | 3/276 |
| Atrioventricular block completeCardiac disorders | 2/276 |
| Cardiac discomfortCardiac disorders | 1/276 |
| PericarditisCardiac disorders | 1/276 |
| Device capturing issueGeneral disorders | 1/276 |
| Incision site infectionInfections and infestations | 1/276 |
| Incision site haemorrhageInjury, poisoning and procedural complications | 1/276 |
| SeromaInjury, poisoning and procedural complications | 1/276 |
| Neurological symptomNervous system disorders | 1/276 |
Patients with a Micra implant attempt
| Age, Continuous(years) | Micra Pacemaker Implant |
|---|---|
| Mean | 76.1 ± 11.9 |
| Sex: Female, Male(Participants) | Micra Pacemaker Implant |
|---|---|
| Female | 121 |
| Male | 155 |
| Ethnicity (NIH/OMB)(Participants) | Micra Pacemaker Implant |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 264 |
| Unknown or Not Reported | 6 |
| Race (NIH/OMB)(Participants) | Micra Pacemaker Implant |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 19 |
| White | 248 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Micra Pacemaker Implant |
|---|---|
| United States | 276 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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