Bradycardia
Conditions
Brief 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).
Detailed description
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.
Interventions
DEVICEMicra Pacemaker Implant
Sponsors
Medtronic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 3 months post last follow up | Micra system and/or procedure-related complication rate |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of the 285 patients that were consented to participate in the study, 276 patients underwent a Micra implant attempt. Nine patients who were consented into the study did not ultimately have a Micra implant attempt prior to study closure.
Participants by arm
| Arm | Count |
|---|---|
| Micra Pacemaker Implant All subjects who attempted Micra implant procedure | 276 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Implant unsuccessful | 7 |
Baseline characteristics
| Characteristic | Micra Pacemaker Implant |
|---|---|
| Age, Continuous | 76.1 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 264 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 248 Participants |
| Region of Enrollment United States | 276 participants |
| Sex: Female, Male Female | 121 Participants |
| Sex: Female, Male Male | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 276 |
| serious Total, serious adverse events | 27 / 276 |
Outcome results
Primary
Complications
Micra system and/or procedure-related complication rate
Time frame: 3 months post last follow up
Population: All subjects who attempted Micra implant procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Micra Pacemaker Implant | Complications | 4 % participants with complication |