Trial Outcomes & Findings for Micra Transcatheter Pacing Study (NCT NCT02004873)
NCT ID: NCT02004873
Last Updated: 2018-01-17
Results Overview
Micra system and/or procedure related major complication free rate at 6-months post-implant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
744 participants
Primary outcome timeframe
Implant to 6 Months Post Implant
Results posted on
2018-01-17
Participant Flow
The study enrolled 744 subjects at 56 centers in 19 countries worldwide between December 2013 and May 2015.
Of the 744 subjects enrolled, 19 exited from the study without attempting Micra implant (7 did not meet inclusion / exclusion criteria, 12 due to other miscellaneous reasons), 6 attempted Micra implant but were unsuccessful, and the remaining 719 subjects were successfully implanted with a Micra device.
Participant milestones
| Measure |
Micra Pacemaker Implant
All subjects who attempted Micra implant procedure
|
|---|---|
|
Overall Study
STARTED
|
725
|
|
Overall Study
Micra Implant Success
|
719
|
|
Overall Study
COMPLETED
|
301
|
|
Overall Study
NOT COMPLETED
|
424
|
Reasons for withdrawal
| Measure |
Micra Pacemaker Implant
All subjects who attempted Micra implant procedure
|
|---|---|
|
Overall Study
Implant unsuccessful
|
6
|
|
Overall Study
Awaiting 6-month visit
|
390
|
|
Overall Study
Missed 6-month visit
|
4
|
|
Overall Study
Death
|
23
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Micra Transcatheter Pacing Study
Baseline characteristics by cohort
| Measure |
Micra Study Enrollments
n=744 Participants
All subjects enrolled in the Micra study
|
|---|---|
|
Age, Continuous
|
75.7 years
STANDARD_DEVIATION 11.0 • n=93 Participants
|
|
Sex/Gender, Customized
Female
|
309 participants
n=93 Participants
|
|
Sex/Gender, Customized
Male
|
434 participants
n=93 Participants
|
|
Sex/Gender, Customized
Missing
|
1 participants
n=93 Participants
|
|
Region of Enrollment
Hungary
|
56 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
297 participants
n=93 Participants
|
|
Region of Enrollment
Japan
|
38 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
30 participants
n=93 Participants
|
|
Region of Enrollment
Malaysia
|
21 participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
54 participants
n=93 Participants
|
|
Region of Enrollment
India
|
19 participants
n=93 Participants
|
|
Region of Enrollment
Greece
|
5 participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=93 Participants
|
|
Region of Enrollment
Austria
|
50 participants
n=93 Participants
|
|
Region of Enrollment
Czech Republic
|
43 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
37 participants
n=93 Participants
|
|
Region of Enrollment
China
|
7 participants
n=93 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
17 participants
n=93 Participants
|
|
Region of Enrollment
South Africa
|
3 participants
n=93 Participants
|
|
Region of Enrollment
Serbia
|
7 participants
n=93 Participants
|
|
Region of Enrollment
France
|
38 participants
n=93 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Implant to 6 Months Post ImplantPopulation: All subjects who attempted Micra implant procedure
Micra system and/or procedure related major complication free rate at 6-months post-implant.
Outcome measures
| Measure |
Micra Pacemaker Implant
n=725 Participants
All subjects who attempted Micra implant procedure
|
|---|---|
|
Major Complications
|
96.0 Kaplan-Meier survival probability (%)
Interval 93.3 to 97.6
|
PRIMARY outcome
Timeframe: 6 Months Post ImplantPopulation: Subjects implanted with Micra who had paired implant and 6-month auto decrement PCT values (at 0.24 ms), or who had a system modification or alternative device implant prior to 6 months due to elevated threshold.
Subjects that have an adequate pacing capture threshold (PCT) at the 6-month post-implant visit, which is defined as PCT \<=2 volts at 0.24 ms pulse width and the increase in PCT from implant to 6 months \<=1.5 volts. The pacing capture threshold is the minimal electrical stimulus required to produce consistent cardiac depolarization. It is the minimum amount of energy that is required for a pacemaker to pace the heart.
Outcome measures
| Measure |
Micra Pacemaker Implant
n=297 Participants
All subjects who attempted Micra implant procedure
|
|---|---|
|
Pacing Capture Threshold
|
292 participants
|
SECONDARY outcome
Timeframe: 6 Months Post ImplantPopulation: Subjects implanted with Micra who had paired ventricular capture management PCT and auto decrement PCT data available at the 6-month visit.
Subjects that have a ventricular capture management threshold (VCMT) that is within 0.5 Volts of the manual (auto decrement) PCT (at 0.24 ms pulse width) at the 6-month post-implant visit. The VCMT is an automatically measured pacing capture threshold that is measured by the Micra device's pacing algorithm. In contrast, the manual (auto decrement) pacing capture threshold is measured by the clinician during a study visit.
Outcome measures
| Measure |
Micra Pacemaker Implant
n=280 Participants
All subjects who attempted Micra implant procedure
|
|---|---|
|
Ventricular Capture Management Threshold
|
279 participants
|
SECONDARY outcome
Timeframe: 3 Months and 6 Months Post Implant (combined analysis)Population: Subjects implanted with Micra who had usable M-PREP test(s) at 3-month and/or 6-month visits.
Assessment of whether the Micra sensor-indicated rate derived from the input of the accelerometer during the Minnesota Pacemaker Response Exercise Protocol (M-PREP) treadmill test conducted at the 3-month and 6-month follow-up visits was proportional to the workload. The sensor-indicated rate (in min\^-1) and workload (in METS) were normalized for each subject relative to their minimum and maximum possible values so the normalized values have a minimum possible value of zero and a maximum possible value of 1. These normalized values were used in a random effect linear regression model to assess the relationship between the sensor-indicated rate and workload via estimation of the Kay-Wilkoff slope parameter. The tests at 3-month and 6-month visits were combined in one analysis.
Outcome measures
| Measure |
Micra Pacemaker Implant
n=30 M-PREP tests
All subjects who attempted Micra implant procedure
|
|---|---|
|
Rate Response Operation of Micra
|
0.864 regression slope parameter
Interval 0.768 to 0.961
|
Adverse Events
Micra Pacemaker Implant
Serious events: 226 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Micra Pacemaker Implant
n=725 participants at risk
All subjects who attempted Micra implant procedure
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.55%
4/725 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.83%
6/725 • Number of events 6 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Angina pectoris
|
0.55%
4/725 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Angina unstable
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Aortic valve stenosis
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
13/725 • Number of events 13 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Atrial flutter
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.69%
5/725 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Bundle branch block right
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Cardiac arrest
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Cardiac failure
|
7.2%
52/725 • Number of events 64 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Cardiac perforation
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Coronary artery disease
|
0.69%
5/725 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Coronary artery stenosis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Palpitations
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
11/725 • Number of events 11 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Pericarditis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Pulseless electrical activity
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Tachycardia induced cardiomyopathy
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Torsade de pointes
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Eye disorders
Cataract
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Gastrointestinal disorders
Subileus
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
General disorders
Asthenia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
General disorders
Chest pain
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
General disorders
Coronary artery restenosis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
General disorders
Death
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
General disorders
Device dislocation
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
General disorders
Device pacing issue
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
General disorders
Multi-organ failure
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
General disorders
Non-cardiac chest pain
|
1.1%
8/725 • Number of events 8 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
General disorders
Pacemaker syndrome
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Arthritis bacterial
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Bacteraemia
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Bronchitis
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Bronchopneumonia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Cellulitis
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Clostridium difficile infection
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Endocarditis
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Epiglottitis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Gastritis viral
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Gastroenteritis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Infected seroma
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Influenza
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Neutropenic sepsis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Osteomyelitis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Pneumonia
|
2.6%
19/725 • Number of events 19 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Pyelonephritis acute
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Sepsis
|
0.83%
6/725 • Number of events 6 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Septic shock
|
0.41%
3/725 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Sinusitis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Infections and infestations
Urinary tract infection
|
1.1%
8/725 • Number of events 8 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Cardiac valve rupture
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Dialysis related complication
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Medication error
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Investigations
International normalised ratio increased
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Metabolism and nutrition disorders
Gout
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Cognitive disorder
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Convulsion
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Dementia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Dizziness
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Epilepsy
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Headache
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Presyncope
|
1.1%
8/725 • Number of events 8 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Syncope
|
0.97%
7/725 • Number of events 7 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Nervous system disorders
Vocal cord paralysis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Psychiatric disorders
Mental status changes
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Renal and urinary disorders
Haematuria
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Renal and urinary disorders
Renal failure
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.55%
4/725 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Renal and urinary disorders
Renal failure chronic
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Renal and urinary disorders
Urinary retention
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.55%
4/725 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Surgical and medical procedures
Incisional drainage
|
0.28%
2/725 • Number of events 2 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Accelerated hypertension
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Arteriovenous fistula
|
0.69%
5/725 • Number of events 5 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Circulatory collapse
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.41%
3/725 • Number of events 3 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Embolism
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Haematoma
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Hypertension
|
0.55%
4/725 • Number of events 4 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Hypertensive crisis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Hypotension
|
0.83%
6/725 • Number of events 6 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Ischaemia
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
|
Vascular disorders
Temporal arteritis
|
0.14%
1/725 • Number of events 1 • From implant attempt to last subject follow-up, ranging from 0 to 14.5 months
|
Other adverse events
Adverse event data not reported
Additional Information
Micra Clinical Team
Medtronic Cardiac Rhythm and Heart Failure
Phone: 800-328-2518
Email: [email protected]
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