Trial Outcomes & Findings for Micra Transcatheter Pacing System Continued Access Study Protocol (NCT NCT02488681)
NCT ID: NCT02488681
Last Updated: 2018-04-12
Results Overview
Micra system and/or procedure-related complication rate
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
285 participants
Primary outcome timeframe
3 months post last follow up
Results posted on
2018-04-12
Participant Flow
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.
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.
Participant milestones
| Measure |
Micra Pacemaker Implant
Patients who underwent a Micra implant attempt
|
|---|---|
|
Overall Study
STARTED
|
276
|
|
Overall Study
COMPLETED
|
269
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Micra Pacemaker Implant
Patients who underwent a Micra implant attempt
|
|---|---|
|
Overall Study
Implant unsuccessful
|
7
|
Baseline Characteristics
Micra Transcatheter Pacing System Continued Access Study Protocol
Baseline characteristics by cohort
| Measure |
Micra Pacemaker Implant
n=276 Participants
All subjects who attempted Micra implant procedure
|
|---|---|
|
Age, Continuous
|
76.1 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
264 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
248 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
276 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post last follow upPopulation: All subjects who attempted Micra implant procedure
Micra system and/or procedure-related complication rate
Outcome measures
| Measure |
Micra Pacemaker Implant
n=276 Participants
All subjects who attempted Micra implant procedure
|
|---|---|
|
Complications
|
4 % participants with complication
Interval 2.0 to 7.0
|
Adverse Events
Micra Pacemaker Implant
Serious events: 27 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Micra Pacemaker Implant
n=276 participants at risk
All subjects who attempted Micra implant procedure
|
|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
0.72%
2/276 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Cardiac disorders
Cardiac perforation
|
0.72%
2/276 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Cardiac disorders
Cardiogenic shock
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Cardiac disorders
Pericardial effusion
|
0.72%
2/276 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
General disorders
Adverse drug reaction
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
General disorders
Device capturing issue
|
0.36%
1/276 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
General disorders
Device pacing issue
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
General disorders
Multi-organ failure
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Infections and infestations
Endocarditis
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Infections and infestations
Sepsis
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
1.1%
3/276 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.72%
2/276 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
Other adverse events
| Measure |
Micra Pacemaker Implant
n=276 participants at risk
All subjects who attempted Micra implant procedure
|
|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
0.72%
2/276 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Cardiac disorders
Cardiac discomfort
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Cardiac disorders
Pericarditis
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
General disorders
Device capturing issue
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
General disorders
Device pacing issue
|
1.4%
4/276 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Infections and infestations
Incision site infection
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
1.1%
3/276 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
|
Nervous system disorders
Neurological symptom
|
0.36%
1/276 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to approximately 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
- Publication restrictions are in place
Restriction type: OTHER