Trial Outcomes & Findings for TD01 Master Study (Safety and Efficacy Study) (NCT NCT02087189)
NCT ID: NCT02087189
Last Updated: 2021-12-03
Results Overview
Non-inferiority of the pacing threshold compared to Linox TD. It is expected, that pacing thresholds of the TD01 leads will be statistically significant lower than 0.8V. Pacing threshold is the minimal electrical stimulus (voltage) required to produce consistent cardiac depolarization (heart contraction). Linox TD is another (predecessor) electrode that is used for comparison.
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
3 month follow-up
Results posted on
2021-12-03
Participant Flow
Participant milestones
| Measure |
ICD/ CRT-D Therapy With TD01 as ICD Lead
enrolled as a patient planned with ICD and TD01 implantation
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
ICD/ CRT-D Therapy With TD01 as ICD Lead
enrolled as a patient planned with ICD and TD01 implantation
|
|---|---|
|
Overall Study
enrolled but did not receive a TD01 as implant
|
2
|
Baseline Characteristics
TD01 Master Study (Safety and Efficacy Study)
Baseline characteristics by cohort
| Measure |
ICD/ CRT-D Therapy With TD01 as ICD Lead
n=28 Participants
patients with TD01 as implanted ICD lead
|
|---|---|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Weight
|
84.5 kg
STANDARD_DEVIATION 19.8 • n=5 Participants
|
|
Height
|
172.0 cm
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Body Mass Index (BMI)
|
28.5 kg/m²
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
30 %
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
NYHA class
NYHA class I
|
2 participants
n=5 Participants
|
|
NYHA class
NYHA class II
|
11 participants
n=5 Participants
|
|
NYHA class
NYHA class III
|
15 participants
n=5 Participants
|
|
NYHA class
NYHA class IV
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 month follow-upPopulation: per protocol analysis
Non-inferiority of the pacing threshold compared to Linox TD. It is expected, that pacing thresholds of the TD01 leads will be statistically significant lower than 0.8V. Pacing threshold is the minimal electrical stimulus (voltage) required to produce consistent cardiac depolarization (heart contraction). Linox TD is another (predecessor) electrode that is used for comparison.
Outcome measures
| Measure |
ICD/ CRT-D Therapy With TD01 as ICD Lead
n=20 Participants
patients with TD01 as implanted ICD lead
|
|---|---|
|
TD01 Pacing Threshold
|
0.5 V
Interval 0.3 to 0.6
|
PRIMARY outcome
Timeframe: 3 month follow-upPopulation: per protocol analysis
Non-inferiority of the sensing amplitude compared to Linox TD. It is expected, that the sensing amplitudes of the TD01 leads will be statistically significant higher than 9.7mV. Sensing amplitude is the value for the measured voltage maximum (mV) during the ventricular depolarization (QRS complex during contraction). Linox TD is another (predecessor) electrode that is used for comparison.
Outcome measures
| Measure |
ICD/ CRT-D Therapy With TD01 as ICD Lead
n=20 Participants
patients with TD01 as implanted ICD lead
|
|---|---|
|
TD01 Sensing Amplitude
|
19.6 mV
Interval 16.1 to 21.4
|
SECONDARY outcome
Timeframe: 3 month follow-upPopulation: full analysis set
SADE-free rate related to TD01. It is expected, that the SADE-free rate is higher than 0.9 (90%). SADE Free Rate is a safety parameter and defined as p = 1 - number of SADEs divided by the number of TD01 leads implanted. Whereby Serious Adverse Device Effects (SADEs) are accounted that relate to the TD01 ICD lead and were observed between implantation until the predefined follow-up time, e.g. the three month follow-up.
Outcome measures
| Measure |
ICD/ CRT-D Therapy With TD01 as ICD Lead
n=28 Participants
patients with TD01 as implanted ICD lead
|
|---|---|
|
SADE-free Rate Related to TD01
|
96.4 percentage of participants
Interval 84.2 to 100.0
|
Adverse Events
ICD/ CRT-D Therapy With TD01 as ICD Lead
Serious events: 19 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
ICD/ CRT-D Therapy With TD01 as ICD Lead
n=28 participants at risk
patient with TD01 as implanted ICD lead
|
|---|---|
|
General disorders
Adverse drug reaction
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Angina pectoris
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
General disorders
Asthenia
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Atrial tachycardia
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Cardiac failure
|
42.9%
12/28 • Number of events 12 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Cardiac failure chronic
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Cardiogenic shock
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Eye disorders
Cataract
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Nervous system disorders
Cerebrovascular accident
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Infections and infestations
Chronic sinusitis
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
General disorders
Condition aggravated
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Coronary artery disease
|
14.3%
4/28 • Number of events 4 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Product Issues
Device lead damage
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Immune system disorders
Drug hypersensitivity
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Gastrointestinal disorders
Duodenal polyp
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Gastrointestinal disorders
Gastric ulcer
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
General disorders
Implant site haematoma
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
General disorders
Inflammation
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Product Issues
Lead dislodgement
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Gastrointestinal disorders
Melaena
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
General disorders
Multiple organ dysfunction syndrome
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Pericardial effusion
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Vascular disorders
Phlebitis
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Infections and infestations
Pneumonia
|
10.7%
3/28 • Number of events 3 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
10.7%
3/28 • Number of events 3 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Cardiac disorders
Pulseless electrical activity
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Gastrointestinal disorders
Rectal polyp
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Renal and urinary disorders
Renal failure
|
17.9%
5/28 • Number of events 5 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Infections and infestations
Rhinitis
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Infections and infestations
Sepsis
|
7.1%
2/28 • Number of events 2 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Gastrointestinal disorders
Subileus
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Vascular disorders
Thrombophlebitis
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
3.6%
1/28 • Number of events 1 • All AEs were systematically recorded for the first two years of patient follow-up. From 24-month follow-up until 60-month follow-up only SADEs related to the investigational device were required to be reported per protocol, but AE reporting remained possible.
AE and SAE were defined according to ISO 14155:2011 in the study protocol.
|
Other adverse events
Adverse event data not reported
Additional Information
Mathias Freudigmann, 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