Trial Outcomes & Findings for The INFUSE - Anterior Myocardial Infarction (AMI) Study (NCT NCT00976521)
NCT ID: NCT00976521
Last Updated: 2013-07-08
Results Overview
The primary endpoint of the INFUSE AMI study is infarct size as a percentage of total left ventricular mass at 30 days as measured by cardiac MRI (cMRI), comparing the pooled randomized active (abciximab) infusion to the pooled non infusion arms, without regard to aspiration.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
452 participants
Primary outcome timeframe
30 Days Post Index Procedure
Results posted on
2013-07-08
Participant Flow
Between 28-Nov-09 and 02-Dec-11, 452 subjects meeting all clinical eligibility criteria were consented and enrolled at 37 US and European sites.
Subjects were randomized in a 1:1:1:1 ratio to each of the randomized groups (abciximab infusion with aspiration, abciximab infusion without aspiration, no infusion with aspiration, no infusion without aspiration).
Participant milestones
| Measure |
Local Infusion, Thrombus Aspiration
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed.
After withdrawing the aspiration catheter, the lesion is crossed with a 1.0 mm, 1.5 mm, or 2.0 mm diameter ClearWay™ RX Infusion Catheter (depending on the lumen diameter created by thrombus aspiration and the reference vessel diameter). If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.
|
Local Infusion, no Aspiration
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.
The initial device used to cross the lesion is a 1.0 mm or 1.5 mm diameter ClearWay™ RX Infusion Catheter (1.0 mm for complete occlusion).
If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.
|
No Local Infusion, Thrombus Aspiration
No local infusion of abciximab, thrombus aspiration.
A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed.
|
No Local Infusion, no Aspiration
No local infusion of abciximab and no thrombus aspiration.
The lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
118
|
111
|
111
|
112
|
|
Overall Study
COMPLETED
|
109
|
99
|
102
|
93
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
9
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The INFUSE - Anterior Myocardial Infarction (AMI) Study
Baseline characteristics by cohort
| Measure |
Local Infusion, Thrombus Aspiration
n=118 Participants
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
|
Local Infusion, no Aspiration
n=111 Participants
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration
|
No Local Infusion, Thrombus Aspiration
n=111 Participants
No local infusion of abciximab, thrombus aspiration.
|
No Local Infusion, no Aspiration
n=112 Participants
No local infusion of abciximab and no thrombus aspiration
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
287 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
165 Participants
n=21 Participants
|
|
Age Continuous
|
60.0 years
n=5 Participants
|
56.0 years
n=7 Participants
|
62.0 years
n=5 Participants
|
62.5 years
n=4 Participants
|
61.0 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
334 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
53 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
27 participants
n=5 Participants
|
23 participants
n=4 Participants
|
99 participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
9 participants
n=4 Participants
|
47 participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
15 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
19 participants
n=5 Participants
|
19 participants
n=4 Participants
|
81 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
30 participants
n=5 Participants
|
26 participants
n=7 Participants
|
32 participants
n=5 Participants
|
34 participants
n=4 Participants
|
122 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 Days Post Index ProcedurePopulation: Evaluable cardiac MRI (cMRI) results at 30 days to assess percentage of total left ventricular mass were available for 181 and 172 patients randomized to intracoronary abciximab infusion versus no abciximab infusion, respectively for the ITT (intention to treat) analysis set.
The primary endpoint of the INFUSE AMI study is infarct size as a percentage of total left ventricular mass at 30 days as measured by cardiac MRI (cMRI), comparing the pooled randomized active (abciximab) infusion to the pooled non infusion arms, without regard to aspiration.
Outcome measures
| Measure |
Abciximab Infusion
n=181 Participants
Abciximab Infusion includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or abciximab infusion arm without aspiration. If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.
|
No Infusion
n=172 Participants
No Infusion includes subjects randomized to either the following two arms: no abciximab infusion with aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion with aspiration, a 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until no further thrombus is being removed. If randomized to no abciximab infusion without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
|
Combined
n=353 Participants
Combined includes subjects randomized to all four arms.
|
|---|---|---|---|
|
Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion
|
15.1 Percentage of Left Ventricular Mass
Interval 6.8 to 22.7
|
17.9 Percentage of Left Ventricular Mass
Interval 10.3 to 25.4
|
17.2 Percentage of Left Ventricular Mass
Interval 7.4 to 23.6
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Evaluable cardiac MRI (cMRI) results at 30 days to assess percentage of total myocardial mass were available for 192 and 190 patients randomized to thrombus aspiration versus no no thrombus aspiration, respectively for the ITT (intention to treat) analysis set.
The major secondary endpoint of the INFUSE AMI Study is infarct size as a percentage of total myocardial mass at 30 days measured by cardiac MRI (cMRI), comparing the pooled randomized aspiration arms to the pooled no aspiration arms, without regard to abciximab infusion.
Outcome measures
| Measure |
Abciximab Infusion
n=192 Participants
Abciximab Infusion includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or abciximab infusion arm without aspiration. If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.
|
No Infusion
n=190 Participants
No Infusion includes subjects randomized to either the following two arms: no abciximab infusion with aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion with aspiration, a 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until no further thrombus is being removed. If randomized to no abciximab infusion without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
|
Combined
n=382 Participants
Combined includes subjects randomized to all four arms.
|
|---|---|---|---|
|
Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration
|
17.0 Percentage of Total Myocardial Mass
Interval 9.0 to 22.8
|
17.3 Percentage of Total Myocardial Mass
Interval 7.1 to 25.5
|
17.2 Percentage of Total Myocardial Mass
Interval 7.4 to 23.6
|
Adverse Events
Local Infusion, Thrombus Aspiration
Serious events: 31 serious events
Other events: 0 other events
Deaths: 0 deaths
Local Infusion, No Aspiration
Serious events: 31 serious events
Other events: 0 other events
Deaths: 0 deaths
No Local Infusion, Thrombus Aspiration
Serious events: 35 serious events
Other events: 0 other events
Deaths: 0 deaths
No Local Infusion, No Aspiration
Serious events: 41 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Local Infusion, Thrombus Aspiration
n=118 participants at risk
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration
|
Local Infusion, No Aspiration
n=111 participants at risk
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.
|
No Local Infusion, Thrombus Aspiration
n=111 participants at risk
No local infusion of abciximab, thrombus aspiration.
|
No Local Infusion, No Aspiration
n=112 participants at risk
No local infusion of abciximab and no thrombus aspiration.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.85%
1/118 • Number of events 2
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.89%
1/112 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Nervous system disorders
Syncope
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.89%
1/112 • Number of events 1
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
1.8%
2/112 • Number of events 2
|
|
Psychiatric disorders
Somatoform disorder cardiovascular
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Renal and urinary disorders
Kidney dysfunction
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.7%
2/118 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
1.8%
2/111 • Number of events 2
|
0.89%
1/112 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Surgical and medical procedures
Blood transfusion
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 2
|
|
Surgical and medical procedures
Chemotherapy
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 2
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Surgical and medical procedures
Implantable cardioverter defibrillator insertion
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
1.8%
2/112 • Number of events 2
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Surgical and medical procedures
Renal dialysis
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Surgical and medical procedures
Resuscitation
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Surgical and medical procedures
Sternotomy
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Vascular disorders
Arterial rupture
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Vascular disorders
Hypotension
|
0.85%
1/118 • Number of events 1
|
1.8%
2/111 • Number of events 2
|
1.8%
2/111 • Number of events 2
|
0.89%
1/112 • Number of events 1
|
|
Vascular disorders
Peripheral ischemia
|
0.85%
1/118 • Number of events 2
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.89%
1/112 • Number of events 1
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Blood and lymphatic system disorders
Anemia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Cardiac disorders
Angina pectoris
|
5.9%
7/118 • Number of events 7
|
6.3%
7/111 • Number of events 8
|
5.4%
6/111 • Number of events 8
|
4.5%
5/112 • Number of events 6
|
|
Cardiac disorders
Angina unstable
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
1.8%
2/112 • Number of events 2
|
|
Cardiac disorders
Cardiac pseudoaneurysm
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Cardiac disorders
Cardiogenic shock
|
0.85%
1/118 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
2.7%
3/112 • Number of events 3
|
|
Cardiac disorders
Congestive heart failure
|
0.85%
1/118 • Number of events 1
|
2.7%
3/111 • Number of events 3
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
1.8%
2/112 • Number of events 2
|
|
Cardiac disorders
Coronary artery perforation
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Cardiac disorders
Heart block
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
0.89%
1/112 • Number of events 1
|
|
Cardiac disorders
Heart failure
|
1.7%
2/118 • Number of events 2
|
3.6%
4/111 • Number of events 4
|
3.6%
4/111 • Number of events 4
|
9.8%
11/112 • Number of events 15
|
|
Cardiac disorders
Interventricular septum rupture
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Cardiac disorders
Intracardiac thrombus
|
1.7%
2/118 • Number of events 2
|
2.7%
3/111 • Number of events 3
|
2.7%
3/111 • Number of events 3
|
0.00%
0/112
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/118
|
0.90%
1/111 • Number of events 2
|
1.8%
2/111 • Number of events 2
|
0.89%
1/112 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Cardiac disorders
Ventricular fibrillation
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Congenital, familial and genetic disorders
Defect interventricular septum
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Gastrointestinal disorders
GI bleed
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
2.7%
3/112 • Number of events 3
|
|
Gastrointestinal disorders
Retroperitoneal bleed
|
0.85%
1/118 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
General disorders
Accidental death
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
General disorders
Cardiac death
|
4.2%
5/118 • Number of events 5
|
1.8%
2/111 • Number of events 2
|
1.8%
2/111 • Number of events 2
|
1.8%
2/112 • Number of events 2
|
|
General disorders
Chest pain
|
1.7%
2/118 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
1.8%
2/111 • Number of events 2
|
1.8%
2/112 • Number of events 2
|
|
General disorders
Chest pain (non-cardiac)
|
0.00%
0/118
|
0.00%
0/111
|
1.8%
2/111 • Number of events 2
|
0.00%
0/112
|
|
General disorders
Impaired healing
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
1.8%
2/112 • Number of events 2
|
|
General disorders
Sudden cardiac death
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
General disorders
Thoracic pain
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
General disorders
Ulcer
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
|
Infections and infestations
Infection systemic
|
0.00%
0/118
|
1.8%
2/111 • Number of events 2
|
0.90%
1/111 • Number of events 1
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Localized infection
|
0.85%
1/118 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.85%
1/118 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
1.8%
2/111 • Number of events 2
|
0.89%
1/112 • Number of events 2
|
|
Infections and infestations
Septic shock
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/118
|
0.90%
1/111 • Number of events 1
|
0.00%
0/111
|
0.00%
0/112
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Injury, poisoning and procedural complications
Aortic stent-graft thrombosis
|
0.00%
0/118
|
0.00%
0/111
|
0.00%
0/111
|
0.89%
1/112 • Number of events 1
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/118
|
1.8%
2/111 • Number of events 2
|
0.00%
0/111
|
0.00%
0/112
|
|
Investigations
Blood pressure decreased
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
0.00%
0/118
|
0.00%
0/111
|
0.90%
1/111 • Number of events 1
|
0.00%
0/112
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.85%
1/118 • Number of events 1
|
0.00%
0/111
|
0.00%
0/111
|
0.00%
0/112
|
Other adverse events
Adverse event data not reported
Additional Information
Leah Hollins, Director of Clinical Affairs
Atrium Medical Corporation
Phone: 603-880-1433
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any proposed manuscript or publication will be submitted to Sponsor and Lead PI for comment at least 60 days prior to release of that manuscript or publication. There will be no publicizing of any data or results without the Sponsor's prior written permission. The publishing party will make every reasonable attempt to incorporate comments received from the Sponsor during such 60-day period.
- Publication restrictions are in place
Restriction type: OTHER