Trial Outcomes & Findings for HEAL-LAA Clinical Trial (NCT NCT05809596)
NCT ID: NCT05809596
Last Updated: 2025-11-04
Results Overview
Incomplete seal with peri-device gap \> 5mm in the primary analysis subset implanted patients with 45-day TEE imaging (as assessed by the core lab).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
949 participants
Primary outcome timeframe
45 days
Results posted on
2025-11-04
Participant Flow
Participant milestones
| Measure |
Primary Analysis Subset
Initial 500 enrolled subjects
|
|---|---|
|
Overall Study
STARTED
|
500
|
|
Overall Study
45-Day Follow-up
|
494
|
|
Overall Study
6-Month Follow-up
|
474
|
|
Overall Study
COMPLETED
|
474
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Primary Analysis Subset
Initial 500 enrolled subjects
|
|---|---|
|
Overall Study
Death
|
16
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Missed Visit
|
2
|
|
Overall Study
Other
|
3
|
Baseline Characteristics
Race calculated for Non-Hispanic or Latino Ethnicity
Baseline characteristics by cohort
| Measure |
Primary Analysis Subset
n=500 Participants
Initial 500 enrolled subjects
|
|---|---|
|
Age, Customized
<75 years
|
188 Participants
n=500 Participants
|
|
Age, Customized
≥ 75 years
|
312 Participants
n=500 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=500 Participants
|
|
Sex: Female, Male
Male
|
306 Participants
n=500 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=500 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
471 Participants
n=500 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=500 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=471 Participants • Race calculated for Non-Hispanic or Latino Ethnicity
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=471 Participants • Race calculated for Non-Hispanic or Latino Ethnicity
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=471 Participants • Race calculated for Non-Hispanic or Latino Ethnicity
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=471 Participants • Race calculated for Non-Hispanic or Latino Ethnicity
|
|
Race (NIH/OMB)
White
|
441 Participants
n=471 Participants • Race calculated for Non-Hispanic or Latino Ethnicity
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=471 Participants • Race calculated for Non-Hispanic or Latino Ethnicity
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=471 Participants • Race calculated for Non-Hispanic or Latino Ethnicity
|
|
Region of Enrollment
United States
|
500 participants
n=500 Participants
|
PRIMARY outcome
Timeframe: 45 daysPopulation: Implanted primary analysis subjects with 45-day TEE imaging.
Incomplete seal with peri-device gap \> 5mm in the primary analysis subset implanted patients with 45-day TEE imaging (as assessed by the core lab).
Outcome measures
| Measure |
Primary Analysis Subset
n=404 Participants
Initial 500 enrolled subjects (subjects who signed an approved Informed Consent Form, meet all clinical inclusion and no clinical exclusion criteria, and the WATCHMAN FLX Pro LAAC Device has been used for treatment and/or attempted to be used for treatment).
|
|---|---|
|
Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 monthsComposite CEC-adjudicated all-cause mortality, all stroke, systemic embolism, and major bleeding in the Intention to Treat (ITT) population at 6 months.
Outcome measures
| Measure |
Primary Analysis Subset
n=494 Participants
Initial 500 enrolled subjects (subjects who signed an approved Informed Consent Form, meet all clinical inclusion and no clinical exclusion criteria, and the WATCHMAN FLX Pro LAAC Device has been used for treatment and/or attempted to be used for treatment).
|
|---|---|
|
Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects
|
54 Participants
|
Adverse Events
Primary Analysis Subset
Serious events: 141 serious events
Other events: 70 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Primary Analysis Subset
n=500 participants at risk
Initial 500 enrolled subjects
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.60%
3/500 • Number of events 3 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Angina pectoris
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Angina unstable
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
13/500 • Number of events 13 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Atrial flutter
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Bradycardia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Cardiac failure acute
|
2.2%
11/500 • Number of events 13 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.8%
9/500 • Number of events 10 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Cardiac tamponade
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Cardiogenic shock
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Cardiomyopathy
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Coronary artery disease
|
0.60%
3/500 • Number of events 3 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Pericardial effusion
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Tachycardia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Eye disorders
Visual impairment
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Colitis
|
0.60%
3/500 • Number of events 3 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Gastrointestinal angiectasia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.4%
12/500 • Number of events 13 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Asthenia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Catheter site discharge
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Catheter site haemorrhage
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Chest pain
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Death
|
0.60%
3/500 • Number of events 3 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Device related thrombosis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Non-cardiac chest pain
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Bronchitis
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
COVID-19
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Cellulitis
|
0.80%
4/500 • Number of events 4 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Cystitis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Influenza
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Joint abscess
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Osteomyelitis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Pneumonia
|
1.0%
5/500 • Number of events 5 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Pneumonia viral
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Sepsis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Septic shock
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
5/500 • Number of events 6 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
5/500 • Number of events 5 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Pharyngeal perforation
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Product Issues
Device extrusion
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial lipoma
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Aphasia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
5/500 • Number of events 5 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Encephalopathy
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.60%
3/500 • Number of events 3 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Headache
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Ischaemic stroke
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Parkinson's disease
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Partial seizures
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Syncope
|
0.20%
1/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Product Issues
Device dislocation
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Product Issues
Device leakage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Psychiatric disorders
Mental status changes
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
6/500 • Number of events 6 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Renal and urinary disorders
End stage renal disease
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Renal and urinary disorders
Haematuria
|
0.20%
1/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Renal and urinary disorders
Urinary retention
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
7/500 • Number of events 7 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
1/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Vascular disorders
Deep vein thrombosis
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Vascular disorders
Haematoma
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Vascular disorders
Hypertensive emergency
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Vascular disorders
Hypotension
|
0.80%
4/500 • Number of events 4 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Vascular disorders
Scalp haematoma
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Vascular disorders
Subgaleal haematoma
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
Other adverse events
| Measure |
Primary Analysis Subset
n=500 participants at risk
Initial 500 enrolled subjects
|
|---|---|
|
General disorders
Oedema peripheral
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Cystitis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Cardiac disorders
Pericardial effusion
|
0.60%
3/500 • Number of events 3 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.80%
4/500 • Number of events 4 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Catheter site bruise
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Catheter site haematoma
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Catheter site haemorrhage
|
0.60%
3/500 • Number of events 3 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Catheter site pain
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
General disorders
Device related thrombosis
|
0.60%
3/500 • Number of events 3 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
7/500 • Number of events 7 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.60%
3/500 • Number of events 3 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.40%
2/500 • Number of events 2 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Investigations
Occult blood positive
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Renal and urinary disorders
Haematuria
|
0.60%
3/500 • Number of events 3 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
10/500 • Number of events 12 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Vascular disorders
Haematoma
|
1.0%
5/500 • Number of events 5 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Vascular disorders
Haemorrhage
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
|
Vascular disorders
Scalp haematoma
|
0.20%
1/500 • Number of events 1 • Study events are reported from enrollment through Day 180, with the exception of All-Cause Mortality which includes mortalities reported from enrollment through 6-month follow-up visit completion, or end of the 6-month visit window (210 days) when the visit was missed.
|
Additional Information
Nicole Kelly, Clinical Trial Manager
Boston Scientific
Phone: 1-800-CARDIAC
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER