Trial Outcomes & Findings for MultiPoint Pacing™ Post Market Study (NCT NCT02832622)
NCT ID: NCT02832622
Last Updated: 2021-02-17
Results Overview
The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline.
Recruitment status
COMPLETED
Target enrollment
2169 participants
Primary outcome timeframe
One year
Results posted on
2021-02-17
Participant Flow
This post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group and the associated results presented.
Participant milestones
| Measure |
MPP Programming
Data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group.
|
|---|---|
|
Overall Study
STARTED
|
2169
|
|
Overall Study
COMPLETED
|
433
|
|
Overall Study
NOT COMPLETED
|
1736
|
Reasons for withdrawal
| Measure |
MPP Programming
Data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group.
|
|---|---|
|
Overall Study
MPP not programmed
|
1259
|
|
Overall Study
Withdrawal by Subject
|
123
|
|
Overall Study
Death
|
119
|
|
Overall Study
Unsuccessful CRT implant
|
93
|
|
Overall Study
Lost to Follow-up
|
45
|
|
Overall Study
Patient non-compliance
|
42
|
|
Overall Study
Withdrawal by other reasons
|
25
|
|
Overall Study
System explant
|
24
|
|
Overall Study
Physician Decision
|
6
|
Baseline Characteristics
A baseline population differs from the overall due to missing data points.
Baseline characteristics by cohort
| Measure |
MPP Group
n=433 Participants
MPP Group: Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Age, Continuous
|
70.4 Age
STANDARD_DEVIATION 10.7 • n=433 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=433 Participants
|
|
Sex: Female, Male
Male
|
316 Participants
n=433 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
338 Participants
n=433 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
35 Participants
n=433 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=433 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
34 Participants
n=433 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=433 Participants
|
|
Region of Enrollment
Colombia
|
3 participants
n=433 Participants
|
|
Region of Enrollment
Argentina
|
4 participants
n=433 Participants
|
|
Region of Enrollment
United States
|
414 participants
n=433 Participants
|
|
Region of Enrollment
Japan
|
12 participants
n=433 Participants
|
|
Quality of Life (MLWHF)
|
39.9 scores on a scale
STANDARD_DEVIATION 28.1 • n=430 Participants • A baseline population differs from the overall due to missing data points.
|
|
Left Ventricular Ejection Fraction
|
29.7 Percentage
STANDARD_DEVIATION 10.4 • n=386 Participants • A baseline population differs from the overall due to missing data points.
|
|
Left Ventricular End-Systolic Volume
|
113.9 mL
STANDARD_DEVIATION 67.7 • n=123 Participants • A baseline population differs from the overall due to missing data points.
|
PRIMARY outcome
Timeframe: One yearPopulation: The analysis population includes any subjects whose device is programmed with MPP.
The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline.
Outcome measures
| Measure |
MPP Group
n=433 Participants
Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Number of CRT Responders as Measured by the Clinical Composite Score (CCS)
|
350 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and one yearPopulation: The analysis population includes any subjects whose device is programmed with MPP.
The change in the Minnesota Living with Heart Failure (MLWHF) questionnaire score between baseline and 12 months (12 months - baseline). MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
Outcome measures
| Measure |
MPP Group
n=406 Participants
Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Change in Quality of Life
|
-17.4 score on a scale
Standard Deviation 24.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One yearPopulation: The analysis population includes any subjects whose device is programmed with MPP.
The duration of MPP programming in months in the treatment groups.
Outcome measures
| Measure |
MPP Group
n=433 Participants
Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Duration of MPP Programming in Months
|
10.43 Months
Standard Deviation 2.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One yearPopulation: The analysis population includes any subjects whose device is programmed with MPP.
The number of MPP programming optimizations per subject
Outcome measures
| Measure |
MPP Group
n=433 Participants
Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Number of MPP Programming Optimizations Per Subject
|
0.73 programming optimizations
Standard Deviation 0.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One yearPopulation: The analysis population includes any subjects whose device is programmed with MPP.
HF event is defined as any one of the following when the subject has symptoms and/or signs consistent with congestive heart failure: * Hospitalization for HF ≥ 24 hours * Clinic or hospital visit for HF\<24 hours (i.e. outpatient treatment, observational care, ER, Urgent Care and physician's office visit) requiring administration of IV diuretics, inotropes, and/or vasodilators
Outcome measures
| Measure |
MPP Group
n=433 Participants
Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Number of Subjects With Heart Failure Hospitalization
|
57 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One yearPopulation: The analysis population includes any subjects whose device is programmed with MPP.
Number of subjects with cardiovascular hospitalization as reported by the sites
Outcome measures
| Measure |
MPP Group
n=433 Participants
Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Number of Subjects With Cardiovascular Hospitalization
|
142 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysPopulation: The analysis population includes any subjects whose device is programmed with MPP.
Number of subjects with heart failure 30-day hospitalization as reported by the sites
Outcome measures
| Measure |
MPP Group
n=433 Participants
Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Number of Subjects With Heart Failure 30-day Hospitalization
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One yearPopulation: The analysis population includes any subjects who started the trial.
Overall mortality rate for all subjects who started the trial is summarized.
Outcome measures
| Measure |
MPP Group
n=2169 Participants
Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Number of Deaths
|
135 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and one yearPopulation: The analysis population includes any subjects whose device is programmed with MPP. LVEF was optional data point in the study. Results were available from a very small number of subjects.
Change in left ventricular ejection fraction between baseline and 12 months (12 months - baseline)
Outcome measures
| Measure |
MPP Group
n=81 Participants
Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Change in Left Ventricular Ejection Fraction
|
11.9 percentage
Standard Deviation 12.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and one yearPopulation: The analysis population includes any subjects whose device is programmed with MPP. LVESV was optional data point in the study. Results were available from a very small number of subjects.
Change in left ventricular end systolic volume between baseline and 12 months (Baseline - 12 months)
Outcome measures
| Measure |
MPP Group
n=20 Participants
Subjects programmed with MPP in the study are included in the analysis population.
|
|---|---|
|
Change in Left Ventricular End Systolic Volume
|
22.5 mL
Standard Deviation 57.3
|
Adverse Events
Overall Study Cohort
Serious events: 821 serious events
Other events: 288 other events
Deaths: 135 deaths
Serious adverse events
| Measure |
Overall Study Cohort
n=2169 participants at risk
All patients who started in the study are included in the all-cause mortality, serious adverse events and/or other adverse events tables.
|
|---|---|
|
Blood and lymphatic system disorders
Abnormal Labs
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Angina
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Cardiac disorders
Aortic Insufficiency
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Aortic Stenosis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atherosclerotic Cardiovascular Disease
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.55%
12/2169 • Number of events 12 • 12 months
|
|
Cardiac disorders
Cardiac Arrhythmias
|
3.3%
72/2169 • Number of events 80 • 12 months
|
|
Cardiac disorders
Cardiac Sarcoidosis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Tamponade
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.28%
6/2169 • Number of events 6 • 12 months
|
|
Cardiac disorders
Carotid Stenosis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Chest Pain
|
0.46%
10/2169 • Number of events 10 • 12 months
|
|
Cardiac disorders
Dilated Cardiomyopathy
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Cardiac disorders
Heart Failure Exacerbation
|
7.7%
168/2169 • Number of events 227 • 12 months
|
|
Cardiac disorders
Hypotension
|
0.23%
5/2169 • Number of events 5 • 12 months
|
|
Cardiac disorders
Hypotensive Shock
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Lightheadedness
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Loss Of Capture
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Mitral Regurgitation
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Multi-Organ Failure
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Cardiac disorders
Non-St-Elevation Myocardial Infarction
|
0.55%
12/2169 • Number of events 14 • 12 months
|
|
Cardiac disorders
Pericardial Effusion
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Cardiac disorders
Pulmonary Edema
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Syncope
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Cardiac disorders
Valve Damage
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Ear and labyrinth disorders
Heart Failure Exacerbation
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Endocrine disorders
Abnormal Labs
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Diabetes
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Dehydration
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Diverticulitis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Excessive Bleeding
|
0.18%
4/2169 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Gallstone
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
0.55%
12/2169 • Number of events 12 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Peritonits
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Abnormal Labs
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Accidental Injury
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Allergic Reaction
|
0.09%
2/2169 • Number of events 3 • 12 months
|
|
General disorders
Altered Mental Status
|
0.18%
4/2169 • Number of events 4 • 12 months
|
|
General disorders
Anemia
|
0.32%
7/2169 • Number of events 7 • 12 months
|
|
General disorders
Ascites
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Cardiac Arrest
|
0.32%
7/2169 • Number of events 7 • 12 months
|
|
General disorders
Cardiac Arrhythmias
|
0.18%
4/2169 • Number of events 4 • 12 months
|
|
General disorders
Cardio-Respiratory Failure
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Chest Pain
|
0.60%
13/2169 • Number of events 13 • 12 months
|
|
General disorders
Confusion
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Death
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
General disorders
Device Discharge
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Diarrhea
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Drug Toxicity
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Dyspnea
|
0.18%
4/2169 • Number of events 5 • 12 months
|
|
General disorders
Encephalopathy
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
General disorders
Excessive Bleeding
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Gastrointestinal Bleeding
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Heart Failure Exacerbation
|
0.23%
5/2169 • Number of events 5 • 12 months
|
|
General disorders
Hematoma/Seroma
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
General disorders
Hepato-Renal Failure
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Hernia
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Hypertension
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Hypotension
|
0.28%
6/2169 • Number of events 6 • 12 months
|
|
General disorders
Hypoxia
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Medication Error
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Metabolic Bone Disease
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Multi-Organ Failure
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
General disorders
Myocardial Infarction
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Nausea and Vomiting
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Non-Cardiac Death
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Pain
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Pericardial Effusion
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Pleural Effusion
|
0.23%
5/2169 • Number of events 5 • 12 months
|
|
General disorders
Pre-Syncope
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Pulmonary Edema
|
0.28%
6/2169 • Number of events 6 • 12 months
|
|
General disorders
Renal Failure
|
0.18%
4/2169 • Number of events 4 • 12 months
|
|
General disorders
Respiratory Failure
|
0.41%
9/2169 • Number of events 9 • 12 months
|
|
General disorders
Rhabdomyolysis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Sepsis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Syncope
|
0.28%
6/2169 • Number of events 6 • 12 months
|
|
General disorders
Twiddler's Syndrome
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Unresponsiveness
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Weakness
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Hepatobiliary disorders
Acute Hepatitis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Cirrhosis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Dyspnea
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Hepatitis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Immune system disorders
Allergic Reaction
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Infections and infestations
Endocarditis
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Infections and infestations
Infection
|
3.7%
80/2169 • Number of events 90 • 12 months
|
|
Infections and infestations
Pneumonia
|
0.23%
5/2169 • Number of events 5 • 12 months
|
|
Infections and infestations
Sepsis
|
0.51%
11/2169 • Number of events 11 • 12 months
|
|
Infections and infestations
Septic Shock
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
0.83%
18/2169 • Number of events 18 • 12 months
|
|
Injury, poisoning and procedural complications
Cardiac Arrhythmias
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Cardiac Tamponade
|
0.23%
5/2169 • Number of events 5 • 12 months
|
|
Injury, poisoning and procedural complications
Cardiac/Coronary Sinus Dissection
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Cardiac/Coronary Sinus Perforation
|
0.18%
4/2169 • Number of events 4 • 12 months
|
|
Injury, poisoning and procedural complications
Deep Vein Thrombosis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Drug Overdose
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Excessive Bleeding
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Hematoma/Seroma
|
0.55%
12/2169 • Number of events 12 • 12 months
|
|
Injury, poisoning and procedural complications
Infection
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Pain
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pericarditis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pneumothorax/Hemothorax
|
0.32%
7/2169 • Number of events 7 • 12 months
|
|
Injury, poisoning and procedural complications
Pulmonary Edema
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pulmonary Hemorrhage
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Renal Failure From Contrast Media Used To Visualize Coronary Veins
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Thrombolytic or Air Embolism
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Wound Site Complications
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Investigations
Abnormal Labs
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Investigations
Chest Pain
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Investigations
Drug Toxicity
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Investigations
Induced Atrial or Ventricular Arrhythmias
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Investigations
Rise in Threshold and Exit Block
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Accidental Injury
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Polyps
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor
|
0.65%
14/2169 • Number of events 14 • 12 months
|
|
Nervous system disorders
Cerebellar Hemorrhage
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Nervous system disorders
Cerebral Hemorrhage
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Nervous system disorders
Glioblastoma
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Nervous system disorders
Stroke
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Product Issues
Cardiac Arrhythmias
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Cardiac/Coronary Sinus Perforation
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Change in Thresholds
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Product Issues
Device Malfunction
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Elevated Defibrillation Threshold
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Induced Atrial or Ventricular Arrhythmias
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Infection
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Lead Dislodgement
|
1.6%
35/2169 • Number of events 38 • 12 months
|
|
Product Issues
Lead/Port Damage
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Loss of Capture
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Product Issues
Loss of Pacing and/or Sensing due to Dislodgement or Mechanical Malfunction of The Pacing Lead
|
0.23%
5/2169 • Number of events 5 • 12 months
|
|
Product Issues
Oversensing
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Pectoral/Diaphragmatic/Phrenic Nerve Stimulation
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Rise in Threshold And Exit Block
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Depression
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Cholecystitis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Dialysis Shunt Occlusion
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Kidney Stones
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.18%
4/2169 • Number of events 4 • 12 months
|
|
Renal and urinary disorders
Renal Failure
|
0.92%
20/2169 • Number of events 23 • 12 months
|
|
Renal and urinary disorders
Renal Transplantation
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.60%
13/2169 • Number of events 14 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.28%
6/2169 • Number of events 10 • 12 months
|
|
Social circumstances
Accidental Injury
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Wound Site Complications
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Vascular disorders
Aneurysm
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Vascular disorders
AV Fistula
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Vascular disorders
Carotid Stenosis
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Vascular disorders
Cerebrovascular Accident
|
0.18%
4/2169 • Number of events 4 • 12 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Vascular disorders
Excessive Bleeding
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Vascular disorders
Limb Ischemia
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Vascular disorders
Occluded Stent
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral Artery Disease
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Vascular disorders
Ruptured Abdominal Aortic Aneurysm
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Vascular disorders
Stroke
|
0.28%
6/2169 • Number of events 6 • 12 months
|
|
Vascular disorders
Thrombolytic or Air Embolism
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Vascular disorders
Transient Ischemic Attack
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Vascular disorders
Ulcer
|
0.05%
1/2169 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Overall Study Cohort
n=2169 participants at risk
All patients who started in the study are included in the all-cause mortality, serious adverse events and/or other adverse events tables.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombolytic or Air Embolism
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Arrhythmias
|
0.32%
7/2169 • Number of events 7 • 12 months
|
|
Cardiac disorders
Dyspnea
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Cardiac disorders
Heart Failure Exacerbation
|
0.18%
4/2169 • Number of events 4 • 12 months
|
|
General disorders
Lead Dislodgement
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Pectoral/Diaphragmatic/Phrenic Nerve Stimulation
|
0.41%
9/2169 • Number of events 9 • 12 months
|
|
General disorders
Allergic Reaction
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
General disorders
Altered Mental Status
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Change in Thresholds
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Chest Pain
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Device Vibration
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Dizziness
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Dyspnea
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Hematoma/Seroma
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
General disorders
Hypertension
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Hypotension
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Loss of Capture
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
General disorders
Pain
|
0.18%
4/2169 • Number of events 4 • 12 months
|
|
General disorders
Loss Of CapturePectoral/Diaphragmatic/Phrenic Nerve Stimulation
|
0.32%
7/2169 • Number of events 8 • 12 months
|
|
General disorders
Pre-Syncope
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Syncope
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
General disorders
Weakness
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Infections and infestations
Infection
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Anemia
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Cardiac/Coronary Sinus Dissection
|
0.23%
5/2169 • Number of events 5 • 12 months
|
|
Injury, poisoning and procedural complications
Deep Vein Thrombosis
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Excessive Bleeding
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Hematoma/Seroma
|
0.60%
13/2169 • Number of events 13 • 12 months
|
|
Injury, poisoning and procedural complications
Infection
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pain
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Pericardial Effusion
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Thrombolytic or Air Embolism
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Transient Ischemic Attack
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Wound Site Complications
|
0.14%
3/2169 • Number of events 3 • 12 months
|
|
Investigations
Increased Impedance
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Investigations
Induced Atrial or Ventricular Arrhythmias
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Change in Thresholds
|
1.0%
22/2169 • Number of events 23 • 12 months
|
|
Product Issues
Device Discharge
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Inappropriate Therapy
|
0.09%
2/2169 • Number of events 2 • 12 months
|
|
Product Issues
Induced Atrial or Ventricular Arrhythmias
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Lead Dislodgement
|
1.5%
32/2169 • Number of events 32 • 12 months
|
|
Product Issues
Lead/Port Damage
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Loss of Capture
|
0.55%
12/2169 • Number of events 12 • 12 months
|
|
Product Issues
Loss of Pacing and/or Sensing due to Dislodgement or Mechanical Malfunction of The Pacing Lead
|
0.32%
7/2169 • Number of events 7 • 12 months
|
|
Product Issues
LV Lead Stylet Malfunction
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Oversensing
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Product Issues
Pectoral/Diaphragmatic/Phrenic Nerve Stimulation
|
4.8%
104/2169 • Number of events 124 • 12 months
|
|
Product Issues
Rise in Threshold and Exit Block
|
0.05%
1/2169 • Number of events 1 • 12 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.09%
2/2169 • Number of events 2 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60