Trial Outcomes & Findings for ECG Belt for CRT Response (NCT NCT03504020)
NCT ID: NCT03504020
Last Updated: 2023-02-03
Results Overview
Relative (%) change in LVESV from the baseline measurement to the 6 month measurement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
498 participants
Primary outcome timeframe
baseline to 6 months
Results posted on
2023-02-03
Participant Flow
* 498 pts enrolled, 55 exits prior to randomization * 443 pts randomized, 35 pts not implanted
Participant milestones
| Measure |
ECG Belt
The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.
\>
\> ECG Belt Research System: The ECG Belt Research System is used to identify the best vector and programming parameters.
|
Control Arm
Standard CRT through 6 months follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
208
|
|
Overall Study
COMPLETED
|
161
|
172
|
|
Overall Study
NOT COMPLETED
|
39
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ECG Belt
n=200 Participants
The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.\>
\> ECG Belt Research System: The ECG Belt Research System is used to identify the best vector and programming parameters.
|
Control Arm
n=208 Participants
Standard CRT through 6 months follow-up.
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 10.4 • n=200 Participants
|
67.8 years
STANDARD_DEVIATION 10.1 • n=208 Participants
|
68.8 years
STANDARD_DEVIATION 10.3 • n=408 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=200 Participants
|
41 Participants
n=208 Participants
|
85 Participants
n=408 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=200 Participants
|
167 Participants
n=208 Participants
|
323 Participants
n=408 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: baseline to 6 monthsPopulation: Patients were only included in the analysis if they completed the Baseline and 6-month visit. For some patients, if the 6-month visit was not available, but the 9-month visit was, then the 9-month visit was used.
Relative (%) change in LVESV from the baseline measurement to the 6 month measurement.
Outcome measures
| Measure |
ECG Belt
n=163 Participants
The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.
\>
\> ECG Belt Research System: The ECG Belt Research System is used to identify the best vector and programming parameters.
|
Control Arm
n=175 Participants
Standard CRT through 6 months follow-up.
|
|---|---|---|
|
Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant.
|
-11.7 Percent Change
Standard Deviation 29.0
|
-14.7 Percent Change
Standard Deviation 29.6
|
Adverse Events
ECG Belt
Serious events: 68 serious events
Other events: 0 other events
Deaths: 12 deaths
Control Arm
Serious events: 52 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
ECG Belt
n=200 participants at risk
The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.
ECG Belt Research System: The ECG Belt Research System is used to identify the best vector and programming parameters.
|
Control Arm
n=208 participants at risk
Standard CRT through 9 months follow-up.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
3/200 • Number of events 4 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
1.0%
2/200 • Number of events 2 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Blood and lymphatic system disorders
Nephrogenic Anaemia
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Cardiac disorders
Accelerated Idioventricular Rhythm
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 2 • Enrollment- 9 months
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
1.0%
2/200 • Number of events 4 • Enrollment- 9 months
|
2.4%
5/208 • Number of events 5 • Enrollment- 9 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/200 • Enrollment- 9 months
|
0.96%
2/208 • Number of events 2 • Enrollment- 9 months
|
|
Cardiac disorders
Arrhythmic Storm
|
1.5%
3/200 • Number of events 3 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Cardiac disorders
Atrial Fibrillation
|
3.0%
6/200 • Number of events 6 • Enrollment- 9 months
|
1.4%
3/208 • Number of events 3 • Enrollment- 9 months
|
|
Cardiac disorders
Atrial Flutter
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Cardiac disorders
Atrial Thrombosis
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Cardiac disorders
Cardiac Arrest
|
1.0%
2/200 • Number of events 2 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Cardiac disorders
Cardiac Failure
|
5.0%
10/200 • Number of events 11 • Enrollment- 9 months
|
3.4%
7/208 • Number of events 17 • Enrollment- 9 months
|
|
Cardiac disorders
Cardiac Failure Acute
|
4.5%
9/200 • Number of events 10 • Enrollment- 9 months
|
0.96%
2/208 • Number of events 3 • Enrollment- 9 months
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
4.0%
8/200 • Number of events 10 • Enrollment- 9 months
|
1.9%
4/208 • Number of events 4 • Enrollment- 9 months
|
|
Cardiac disorders
Cardiac Tamponade
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Cardiac disorders
Cardiac Ventricular Thrombosis
|
1.0%
2/200 • Number of events 2 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Cardiac disorders
Cardiogenic Shock
|
1.0%
2/200 • Number of events 3 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Cardiac disorders
Chronic Left Ventricular Failure
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Cardiac disorders
Mitral Valve Incompetence
|
1.0%
2/200 • Number of events 2 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Cardiac disorders
Pericardial Effusion
|
1.0%
2/200 • Number of events 3 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Cardiac disorders
Pulseless Electrical Activity
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/200 • Enrollment- 9 months
|
0.96%
2/208 • Number of events 2 • Enrollment- 9 months
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.96%
2/208 • Number of events 2 • Enrollment- 9 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
2.5%
5/200 • Number of events 6 • Enrollment- 9 months
|
0.96%
2/208 • Number of events 2 • Enrollment- 9 months
|
|
Endocrine disorders
Hypothyroidism
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Eye disorders
Cataract
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/200 • Enrollment- 9 months
|
0.96%
2/208 • Number of events 2 • Enrollment- 9 months
|
|
General disorders
Asthenia
|
1.0%
2/200 • Number of events 2 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
General disorders
Inflammation
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
General disorders
Unevaluable Event
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Immune system disorders
Transplant Rejection
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Infections and infestations
Bacteraemia
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Infections and infestations
Covid-19
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Infections and infestations
Endocarditis
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Infections and infestations
Endocarditis Enterococcal
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Infections and infestations
Escherichia Infection
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Infections and infestations
Implant Site Infection
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Infections and infestations
Parotitis
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Infections and infestations
Pneumonia
|
1.0%
2/200 • Number of events 3 • Enrollment- 9 months
|
0.96%
2/208 • Number of events 2 • Enrollment- 9 months
|
|
Infections and infestations
Pneumonia Escherichia
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Infections and infestations
Sepsis
|
1.5%
3/200 • Number of events 3 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Infections and infestations
Septic Shock
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.96%
2/208 • Number of events 4 • Enrollment- 9 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Investigations
Liver Function Test Increased
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Metabolism and nutrition disorders
Gout
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Metabolism and nutrition disorders
Hyperglycaemic Hyperosmolar Nonketotic Syndrome
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.0%
2/200 • Number of events 2 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 2 • Enrollment- 9 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Haematoma
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Musculoskeletal and connective tissue disorders
Neuropathic Arthropathy
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Peritoneum
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Nervous system disorders
Cauda Equina Syndrome
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.0%
2/200 • Number of events 2 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Nervous system disorders
Presyncope
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/200 • Enrollment- 9 months
|
0.96%
2/208 • Number of events 2 • Enrollment- 9 months
|
|
Product Issues
Device Lead Damage
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Product Issues
Lead Dislodgement
|
2.0%
4/200 • Number of events 4 • Enrollment- 9 months
|
2.9%
6/208 • Number of events 6 • Enrollment- 9 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.0%
2/200 • Number of events 2 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Renal and urinary disorders
End Stage Renal Disease
|
1.0%
2/200 • Number of events 3 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Renal and urinary disorders
Renal Impairment
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.5%
3/200 • Number of events 3 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/200 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
2/200 • Number of events 2 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.0%
2/200 • Number of events 2 • Enrollment- 9 months
|
0.96%
2/208 • Number of events 2 • Enrollment- 9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Vascular disorders
Aortic Aneurysm
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.48%
1/208 • Number of events 1 • Enrollment- 9 months
|
|
Vascular disorders
Intermittent Claudication
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.50%
1/200 • Number of events 2 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
|
Vascular disorders
Shock Haemorrhagic
|
0.50%
1/200 • Number of events 1 • Enrollment- 9 months
|
0.00%
0/208 • Enrollment- 9 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site will not independently publish, publicly disclose, present or discuss any results of or information pertaining to the study until a multi-center publication is released; provide however that if a multi-center publication is not released within 1 year after completion of the study at all sites involved in the study, Study Site will have the right to publish the results of, and information pertaining to , their activities conducted under their CTA, in accordance with provision of CTA.
- Publication restrictions are in place
Restriction type: OTHER