Trial Outcomes & Findings for Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep) (NCT NCT04025710)
NCT ID: NCT04025710
Last Updated: 2024-11-27
Results Overview
SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
167 participants
Primary outcome timeframe
3 months
Results posted on
2024-11-27
Participant Flow
167 patients completed the informed consent process and signed the informed consent sheet. 166 patients successfully received the investigational device, the BM III.
March 18, 2020: temporary suspension of the enrollment due to the Covid-19 pandemic was announced. All investigators were informed about it and continuation of the follow-up phase. Instructions were given for the safety reporting, deviations from follow-up plan, and reporting of deviation in case these processes are impaired by Covid-19 situation. The suspension was lifted site by site based on pre-specified criteria between June 24, 2020 and February 5, 2021.
Participant milestones
| Measure |
All Patients
BIOMONITOR III and BIOMONITOR IIIm: - Insertion of BIOMONITOR III or BIOMONITOR IIIm
* three scheduled in-office follow-ups
* 48-hour Holter ECG
|
|---|---|
|
Overall Study
STARTED
|
167
|
|
Overall Study
COMPLETED
|
116
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
All Patients
BIOMONITOR III and BIOMONITOR IIIm: - Insertion of BIOMONITOR III or BIOMONITOR IIIm
* three scheduled in-office follow-ups
* 48-hour Holter ECG
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Patient unable or unwilling to attend required visits
|
8
|
|
Overall Study
Drop-out according to protocol
|
34
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Patients
n=167 Participants
BIOMONITOR III and BIOMONITOR IIIm: - Insertion of BIOMONITOR III or BIOMONITOR IIIm
* three scheduled in-office follow-ups
* 48-hour Holter ECG
|
|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 15.2 • n=167 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=167 Participants
|
|
Region of Enrollment
Australia
|
22 participants
n=167 Participants
|
|
Region of Enrollment
Austria
|
23 participants
n=167 Participants
|
|
Region of Enrollment
Switzerland
|
8 participants
n=167 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=167 Participants
|
|
Region of Enrollment
Spain
|
14 participants
n=167 Participants
|
|
Region of Enrollment
Germany
|
97 participants
n=167 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All patients who either had a primary endpoint or who had reached 3 months of follow-up
SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up
Outcome measures
| Measure |
All Patients
n=159 Participants
BIOMONITOR III and BIOMONITOR IIIm: - Insertion of BIOMONITOR III or BIOMONITOR IIIm
* three scheduled in-office follow-ups
* 48-hour Holter ECG
|
|---|---|
|
SADE-free Rate Until the 3-month Follow-up
|
141 Participants
|
SECONDARY outcome
Timeframe: 10 days to 4 weeks after insertion; 3-monthsThe secondary endpoint 1 evaluates the R-wave amplitude at the 1st follow-up and at 3-month follow-up by measuring both, the lowest and the highest amplitude value via the programmer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 days to 4 weeks after insertion; 3-monthsThe secondary endpoint 2 evaluates the noise burden at the 1st follow-up and at 3-month follow-up by retrieving the percentage of noise via the programmer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 days to 4 weeks after insertion; 3-monthsThe secondary endpoint 3 evaluates the P-wave visibility at 1st, 3- and 12-month follow-up. The investigator will evaluate whether P-waves can be recognized in the stored sECGs showing sinus rhythm. The number of heart cycles and observed P-waves which can undoubtly be identified in ECGs will be assessed by the investigator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12-monthsThe secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.
Outcome measures
Outcome data not reported
Adverse Events
All Patients
Serious events: 103 serious events
Other events: 59 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
All Patients
n=167 participants at risk
BIOMONITOR III and BIOMONITOR IIIm: - Insertion of BIOMONITOR III or BIOMONITOR IIIm
* three scheduled in-office follow-ups
* 48-hour Holter ECG
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Adverse drug reaction
|
3.6%
6/167 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Antisynthetase syndrome
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Aortic valve stenosis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Aphasia
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
13.8%
23/167 • Number of events 24 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
1.8%
3/167 • Number of events 3 • 1 year
|
|
Cardiac disorders
Atrioventricular block
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrioventricular block complete
|
4.2%
7/167 • Number of events 7 • 1 year
|
|
Eye disorders
Blepharospasm
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Investigations
Blood glucose increased
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bradycardia
|
4.2%
7/167 • Number of events 7 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
4.8%
8/167 • Number of events 8 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Chest pain
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Vascular disorders
Circulatory collapse
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Condition aggravated
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cor pulmonale
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Infections and infestations
Corona virus infection
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
General disorders
Cyst
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Deafness
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Death
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Product Issues
Device dislocation
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Product Issues
Device extrusion
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Dilatation atrial
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diverticulum
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Investigations
Ejection fraction decreased
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Nervous system disorders
Epilepsy
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Head injury
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Investigations
Heart rate increased
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Hypertensive heart disease
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Implant site haematoma
|
0.60%
1/167 • Number of events 2 • 1 year
|
|
General disorders
Implant site haemorrhage
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Infections and infestations
Implant site infection
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Implant site pain
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Infections and infestations
Influenza
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Product Issues
Lead dislodgement
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Left atrial dilatation
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
1.8%
3/167 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Investigations
Oxygen saturation decreased
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Cardiac disorders
Palpitations
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Presyncope
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/167 • Number of events 3 • 1 year
|
|
Infections and infestations
Respiratory tract infection
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Right ventricular dilatation
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinoatrial block
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus arrest
|
3.0%
5/167 • Number of events 5 • 1 year
|
|
Cardiac disorders
Sinus arrhythmia
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Cardiac disorders
Sinus node dysfunction
|
2.4%
4/167 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.4%
4/167 • Number of events 5 • 1 year
|
|
Nervous system disorders
Syncope
|
3.6%
6/167 • Number of events 6 • 1 year
|
|
Nervous system disorders
Tension headache
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Investigations
Troponin increased
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
3.0%
5/167 • Number of events 5 • 1 year
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Eye disorders
Visual impairment
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.60%
1/167 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
All Patients
n=167 participants at risk
BIOMONITOR III and BIOMONITOR IIIm: - Insertion of BIOMONITOR III or BIOMONITOR IIIm
* three scheduled in-office follow-ups
* 48-hour Holter ECG
|
|---|---|
|
General disorders
Impaired healing
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Implant site bruising
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
General disorders
Implant site haematoma
|
1.8%
3/167 • Number of events 3 • 1 year
|
|
General disorders
Implant site haemorrhage
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Infections and infestations
Implant site infection
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Implant site pain
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Implant site reaction
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Influenza like illness
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Intercepted medication error
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Investigations
International normalised ratio fluctuation
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Loss of consciousness
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Malaise
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
General disorders
Medical device site discomfort
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Munchausen's syndrome
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Orthostatic intolerance
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Product Issues
Oversensing
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Social circumstances
Patient dissatisfaction with device
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Peripheral swelling
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Seizure
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Social circumstances
Social problem
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.8%
3/167 • Number of events 3 • 1 year
|
|
Nervous system disorders
Syncope
|
1.8%
3/167 • Number of events 4 • 1 year
|
|
Cardiac disorders
Tachycardia
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Product Issues
Undersensing
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Vascular disorders
Varicose vein
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Eye disorders
Visual impairment
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Adverse drug reaction
|
3.6%
6/167 • Number of events 6 • 1 year
|
|
Nervous system disorders
Amnesia
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Antisynthetase syndrome
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety disorder
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Nervous system disorders
Balance disorder
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Investigations
Blood potassium decreased
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bradycardia
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Chest discomfort
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
General disorders
Chest pain
|
2.4%
4/167 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
General disorders
Condition aggravated
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Deafness
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Product Issues
Device dislocation
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Product Issues
Device physical property issue
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Nervous system disorders
Dizziness
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Nervous system disorders
Epilepsy
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Eye disorders
Eye haemorrhage
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
3/167 • Number of events 5 • 1 year
|
|
General disorders
Fatigue
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Head injury
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Investigations
Heart rate increased
|
1.2%
2/167 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.60%
1/167 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
0.60%
1/167 • Number of events 1 • 1 year
|
Additional Information
Senior Director Clinical Project Management
BIOTRONIK SE & Co.KG
Phone: +49 30 68905
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place