Trial Outcomes & Findings for Attain Stability™ Quad Clinical Study (NCT NCT03099655)
NCT ID: NCT03099655
Last Updated: 2020-01-09
Results Overview
Subjects free of Model 4798 lead-related complications at 6 months post-implant -Model 4798 lead will be considered safe if the probability of subjects free from Attain Stability Quad lead-related complications at 6-months post implant is greater than 87% (i.e. the one-sided 97.5% lower confidence bound must be greater than 87%). Complications were defined in the protocol as, "An adverse event that includes the following is considered a complication: Results in death, Involves any termination of significant device function, or Requires an invasive intervention". Relationship of complication to the Attain Stability Quad lead was determined by an independent Clinical Events Committee.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
471 participants
Primary outcome timeframe
Implant to 6 months post-implant
Results posted on
2020-01-09
Participant Flow
Out of 471 initial enrollments;31 were excluded due to the following: 1. No implant attempted(23) 2. Investigator deemed not medically necessary(4) 3. Insurance declined coverage(2) 4. Patient did not meet criteria for the study(1) 5. Investigator withdrew, not a good candidate(1) Resulting in 440 subjects with 4798 Lead implant attempted
Participant milestones
| Measure |
Attain Stability Quad Lead
Attain Stability Quad Lead (Model 4798) - Single arm study.
Attain Stability Quad Left Ventricular Pacing Lead: cardiac stimulation
|
|---|---|
|
Overall Study
STARTED
|
440
|
|
Overall Study
COMPLETED
|
379
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Attain Stability™ Quad Clinical Study
Baseline characteristics by cohort
| Measure |
Attain Stability Quad Lead
n=440 Participants
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
329 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
312 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
314 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Implant to 6 months post-implantPopulation: Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
Subjects free of Model 4798 lead-related complications at 6 months post-implant -Model 4798 lead will be considered safe if the probability of subjects free from Attain Stability Quad lead-related complications at 6-months post implant is greater than 87% (i.e. the one-sided 97.5% lower confidence bound must be greater than 87%). Complications were defined in the protocol as, "An adverse event that includes the following is considered a complication: Results in death, Involves any termination of significant device function, or Requires an invasive intervention". Relationship of complication to the Attain Stability Quad lead was determined by an independent Clinical Events Committee.
Outcome measures
| Measure |
Attain Stability Quad Lead
n=440 Participants
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
Lead Complication-free Rate at 6 Months
|
97.59 Survival Probability (% of subjects)
Interval 96.12 to 100.0
|
PRIMARY outcome
Timeframe: 6 months post-implantPopulation: Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
The Model 4798 LV lead has sixteen (16) programmable pacing vectors. The endpoint for the primary efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V. -Model 4798 lead will be considered effective if the proportion of subjects with at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.
Outcome measures
| Measure |
Attain Stability Quad Lead
n=377 Participants
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
Proportion (Reported as a Percent) of Subjects With at Least One Vector Having PCT ≤2.5 V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)
|
96.29 Percent of Subjects
Interval 93.85 to 100.0
|
PRIMARY outcome
Timeframe: 6 months post-implantPopulation: All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected 6 months post-implant follow-up visit.
The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the primary efficacy. -Model 4798 lead will be considered effective if the proportion of subjects with at least one additional Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 4.0 V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.
Outcome measures
| Measure |
Attain Stability Quad Lead
n=377 Participants
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
Proportion (Reported as a Percent) of Subjects With at Least One Extra Vector Having PCT ≤ 4.0V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)
|
94.16 Percent of Subjects
Interval 91.3 to 100.0
|
SECONDARY outcome
Timeframe: During procedurePopulation: Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure
Outcome measures
| Measure |
Attain Stability Quad Lead
n=440 Participants
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
Implant Success
|
96.8 Percent of Subjects
Interval 94.7 to 98.3
|
SECONDARY outcome
Timeframe: During procedurePopulation: Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
Summary statistics including mean and standard deviation will be obtained for total implant procedure time (minutes), fluoroscopy time, and cannulation time for each successful implant procedure.
Outcome measures
| Measure |
Attain Stability Quad Lead
n=426 Participants
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
Implant Duration
Implant Procedure Time
|
93 Minutes
Standard Deviation 40
|
|
Implant Duration
Fluoroscopy
|
19 Minutes
Standard Deviation 15
|
|
Implant Duration
Cannulation
|
7 Minutes
Standard Deviation 11
|
SECONDARY outcome
Timeframe: Implant to 6 months post-implantPopulation: Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
Summary statistics including mean and standard deviation will be obtained for PCT (volt) measured at 6-month post implant visit for each successful implanted subject with valid pacing data collected at 6 months post implant follow-up visit.
Outcome measures
| Measure |
Attain Stability Quad Lead
n=426 Participants
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
LV Pacing Capture Threshold (PCT) at 6 Months
|
1.07 Volts
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Implant to 6 monthsPopulation: Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
Summary statistics including mean and standard deviation will be obtained for Pacing Impedance (Ohm) measured at 6-month post implant visit for each successful implanted subject
Outcome measures
| Measure |
Attain Stability Quad Lead
n=426 Participants
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
LV Impedance at 6 Months
|
557.7 Ohms
Standard Deviation 179.5
|
SECONDARY outcome
Timeframe: Implant to 6 monthsPopulation: Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
Number of subjects with a given complication from implant through 6 months (183 days) by total number of subjects undergo Attain Stability implant procedure
Outcome measures
| Measure |
Attain Stability Quad Lead
n=426 Participants
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
Post Implant Lead Failure Rate
Device Connection Issue
|
0.23 Percent of Subjects
Interval 0.01 to 1.3
|
|
Post Implant Lead Failure Rate
Device Pacing Issue
|
0.23 Percent of Subjects
Interval 0.01 to 1.3
|
|
Post Implant Lead Failure Rate
Device Stimulation Issue
|
0.70 Percent of Subjects
Interval 0.15 to 2.2
|
|
Post Implant Lead Failure Rate
Lead Dislodgement
|
0.70 Percent of Subjects
Interval 0.15 to 2.2
|
|
Post Implant Lead Failure Rate
Infection
|
0.23 Percent of Subjects
Interval 0.01 to 1.3
|
|
Post Implant Lead Failure Rate
Ventricular Tachycardia
|
0.23 Percent of Subjects
Interval 0.01 to 1.3
|
Adverse Events
Attain Stability Quad Lead
Serious events: 147 serious events
Other events: 27 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Attain Stability Quad Lead
n=440 participants at risk
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
7/440 • Number of events 8 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.68%
3/440 • Number of events 4 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
16/440 • Number of events 17 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Atrial flutter
|
0.68%
3/440 • Number of events 3 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Bradycardia
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Cardiac arrest
|
0.91%
4/440 • Number of events 4 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Cardiac failure
|
2.5%
11/440 • Number of events 12 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Cardiac failure acute
|
4.1%
18/440 • Number of events 21 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.4%
15/440 • Number of events 17 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Cardiac perforation
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Cardiac tamponade
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Palpitations
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Pericardial effusion
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Pericarditis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.23%
1/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.0%
9/440 • Number of events 9 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Eye disorders
Retinal artery occlusion
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Gastrointestinal disorders
Constipation
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Gastrointestinal disorders
Femoral hernia incarcerated
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.4%
6/440 • Number of events 6 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.68%
3/440 • Number of events 3 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
General disorders
Death
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
General disorders
Hernia
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
General disorders
Implant site haematoma
|
1.8%
8/440 • Number of events 8 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
General disorders
Implant site pain
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
General disorders
Non-cardiac chest pain
|
0.91%
4/440 • Number of events 4 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
General disorders
Sudden cardiac death
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Immune system disorders
Amyloidosis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Bacteraemia
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Bronchitis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Cellulitis
|
0.68%
3/440 • Number of events 4 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Diverticulitis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Gangrene
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Implant site infection
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Influenza
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Osteomyelitis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Periorbital cellulitis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Pneumonia
|
2.0%
9/440 • Number of events 10 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Pneumonia viral
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Pyelitis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Sepsis
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Septic shock
|
0.68%
3/440 • Number of events 3 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
5/440 • Number of events 6 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Cardiac vein perforation
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.68%
3/440 • Number of events 3 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Incision site inflammation
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Investigations
Clostridium test positive
|
0.23%
1/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Investigations
International normalised ratio increased
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Investigations
White blood cell count increased
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Metabolism and nutrition disorders
Obesity
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spinal cord
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Nervous system disorders
Encephalopathy
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Nervous system disorders
Presyncope
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Nervous system disorders
Seizure
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Nervous system disorders
Spinal cord compression
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Nervous system disorders
Syncope
|
0.91%
4/440 • Number of events 5 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Product Issues
Device connection issue
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Product Issues
Device inappropriate shock delivery
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Product Issues
Device pacing issue
|
0.68%
3/440 • Number of events 3 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Product Issues
Device stimulation issue
|
0.68%
3/440 • Number of events 3 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Product Issues
Lead dislodgement
|
2.7%
12/440 • Number of events 12 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Product Issues
Oversensing
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
10/440 • Number of events 11 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Renal and urinary disorders
End stage renal disease
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Renal and urinary disorders
Haematuria
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Renal and urinary disorders
Nephropathy
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Renal and urinary disorders
Renal impairment
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.68%
3/440 • Number of events 3 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Surgical and medical procedures
Medical device change
|
0.45%
2/440 • Number of events 2 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Vascular disorders
Dry gangrene
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Vascular disorders
Femoral artery embolism
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Vascular disorders
Hypertensive emergency
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Vascular disorders
Hypotension
|
1.1%
5/440 • Number of events 5 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Vascular disorders
Intermittent claudication
|
0.45%
2/440 • Number of events 3 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Vascular disorders
Peripheral ischaemia
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.23%
1/440 • Number of events 1 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
Other adverse events
| Measure |
Attain Stability Quad Lead
n=440 participants at risk
Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
|
|---|---|
|
Product Issues
Device stimulation issue
|
6.1%
27/440 • Number of events 31 • Date of implant (or attempted implant) through study completion, an average of 6.42 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER