Trial Outcomes & Findings for Respicardia, Inc. Pivotal Trial of the remedē System (NCT NCT01816776)
NCT ID: NCT01816776
Last Updated: 2018-06-29
Results Overview
Comparison of the proportion of subjects in the Treatment group achieving a 50% or greater reduction in AHI from baseline to 6 months compared to the Control group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
6 months
Results posted on
2018-06-29
Participant Flow
Participant milestones
| Measure |
Treatment Group
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
78
|
|
Overall Study
6 Month Primary Effectiveness Assessed
|
68
|
73
|
|
Overall Study
COMPLETED
|
60
|
70
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ejection fraction data not available on all subjects
Baseline characteristics by cohort
| Measure |
Treatment Group
n=73 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
n=78 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 12 • n=73 Participants
|
65 years
STANDARD_DEVIATION 13 • n=78 Participants
|
65 years
STANDARD_DEVIATION 13 • n=151 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=73 Participants
|
6 Participants
n=78 Participants
|
16 Participants
n=151 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=73 Participants
|
72 Participants
n=78 Participants
|
135 Participants
n=151 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=73 Participants
|
4 Participants
n=78 Participants
|
5 Participants
n=151 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=73 Participants
|
74 Participants
n=78 Participants
|
146 Participants
n=151 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=73 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=151 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=73 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=151 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=73 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=151 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=73 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=151 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=73 Participants
|
3 Participants
n=78 Participants
|
6 Participants
n=151 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=73 Participants
|
74 Participants
n=78 Participants
|
144 Participants
n=151 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=73 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=151 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=73 Participants
|
1 Participants
n=78 Participants
|
1 Participants
n=151 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=73 Participants
|
50 participants
n=78 Participants
|
99 participants
n=151 Participants
|
|
Region of Enrollment
Poland
|
10 participants
n=73 Participants
|
11 participants
n=78 Participants
|
21 participants
n=151 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=73 Participants
|
17 participants
n=78 Participants
|
31 participants
n=151 Participants
|
|
Apnea-Hypopnea Index (AHI)
|
48.8 Events/hour
STANDARD_DEVIATION 19.3 • n=73 Participants
|
43.7 Events/hour
STANDARD_DEVIATION 16.8 • n=78 Participants
|
46.2 Events/hour
STANDARD_DEVIATION 18.2 • n=151 Participants
|
|
Central Apnea Index (CAI)
|
30.0 Events/hour
STANDARD_DEVIATION 18.0 • n=73 Participants
|
26.6 Events/hour
STANDARD_DEVIATION 16.1 • n=78 Participants
|
28.2 Events/hour
STANDARD_DEVIATION 17.1 • n=151 Participants
|
|
Arousal Index (ArI)
|
45.5 Events/hour
STANDARD_DEVIATION 17.9 • n=73 Participants
|
43.6 Events/hour
STANDARD_DEVIATION 19.1 • n=78 Participants
|
44.6 Events/hour
STANDARD_DEVIATION 18.5 • n=151 Participants
|
|
Rapid Eye Movement Sleep (REM)
|
10.4 Percent
STANDARD_DEVIATION 7.2 • n=73 Participants
|
11.8 Percent
STANDARD_DEVIATION 7.1 • n=78 Participants
|
11.1 Percent
STANDARD_DEVIATION 7.1 • n=151 Participants
|
|
Oxygen Desaturation Index (ODI4)
|
43.2 Events/hour
STANDARD_DEVIATION 21.7 • n=73 Participants
|
37.5 Events/hour
STANDARD_DEVIATION 17.5 • n=78 Participants
|
40.2 Events/hour
STANDARD_DEVIATION 19.8 • n=151 Participants
|
|
Obstructive Apnea Index
|
2.6 Events/hour
STANDARD_DEVIATION 3.2 • n=73 Participants
|
2.3 Events/hour
STANDARD_DEVIATION 2.7 • n=78 Participants
|
2.4 Events/hour
STANDARD_DEVIATION 3.0 • n=151 Participants
|
|
Epworth Sleepiness Scale (ESS)
|
10.2 units on a scale
STANDARD_DEVIATION 5.2 • n=73 Participants
|
9.5 units on a scale
STANDARD_DEVIATION 5.8 • n=78 Participants
|
9.8 units on a scale
STANDARD_DEVIATION 5.5 • n=151 Participants
|
|
Body mass index (BMI)
|
30.8 kg/m2
STANDARD_DEVIATION 5.3 • n=73 Participants
|
31.3 kg/m2
STANDARD_DEVIATION 6.6 • n=78 Participants
|
31.1 kg/m2
STANDARD_DEVIATION 6.0 • n=151 Participants
|
|
Hypertension
|
53 Participants
n=73 Participants
|
60 Participants
n=78 Participants
|
113 Participants
n=151 Participants
|
|
Heart failure
|
48 Participants
n=73 Participants
|
48 Participants
n=78 Participants
|
96 Participants
n=151 Participants
|
|
Left ventricular ejection fraction
|
39.7 Percent
STANDARD_DEVIATION 12.1 • n=71 Participants • Ejection fraction data not available on all subjects
|
39.4 Percent
STANDARD_DEVIATION 12.2 • n=75 Participants • Ejection fraction data not available on all subjects
|
39.6 Percent
STANDARD_DEVIATION 12.1 • n=146 Participants • Ejection fraction data not available on all subjects
|
|
Atrial fibrillation
|
32 Participants
n=73 Participants
|
32 Participants
n=78 Participants
|
64 Participants
n=151 Participants
|
|
Stroke
|
6 Participants
n=73 Participants
|
6 Participants
n=78 Participants
|
12 Participants
n=151 Participants
|
|
Coronary artery disease
|
40 Participants
n=73 Participants
|
44 Participants
n=78 Participants
|
84 Participants
n=151 Participants
|
|
Concomitant implantable device delivering therapy
|
31 Participants
n=73 Participants
|
33 Participants
n=78 Participants
|
64 Participants
n=151 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The population analyzed included all randomized participants who had a 6 month assessment. In addition, Treatment group subjects who did not have a 6 month assessment for reasons related to implant, device or delivered therapy were included as not achieving the endpoint.
Comparison of the proportion of subjects in the Treatment group achieving a 50% or greater reduction in AHI from baseline to 6 months compared to the Control group.
Outcome measures
| Measure |
Treatment Group
n=68 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
n=73 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
|---|---|---|
|
The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI)
|
35 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat. The study protocol pre-specified that randomized groups be combined to assess freedom from related serious adverse events within 12 months.
Freedom from serious adverse events (SAEs) associated with the implant procedure, the remede System, or the delivered therapy at 12 months post therapy initiation visit.
Outcome measures
| Measure |
Treatment Group
n=151 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
|---|---|---|
|
Freedom From Related Serious Adverse Events Within 12 Months
|
138 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to "off" at the 6-month visit, did not have 6-month polysomnogram (PSG) results or had unsuccessful implant attempt.
Change in CAI = Month 6 index - Baseline index. The central apnea index is a measurement used to indicate the severity of central sleep apnea. It is represented by the number of central apnea events per hour of sleep.
Outcome measures
| Measure |
Treatment Group
n=58 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
n=73 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
|---|---|---|
|
Central Apnea Index (CAI) Change From Baseline at 6 Months
|
-25.7 Events/hour
Interval -30.5 to -21.0
|
-2.9 Events/hour
Interval -7.0 to 1.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to "off" at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt.
Change in AHI = Month 6 index - Baseline index. The Apnea-Hypopnea Index is a measurement used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
Outcome measures
| Measure |
Treatment Group
n=58 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
n=73 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
|---|---|---|
|
Apnea-Hypopnea Index (AHI) Change From Baseline at 6 Months
|
-23.9 Events/hour
Interval -28.8 to -19.0
|
1.1 Events/hour
Interval -3.0 to 5.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to "off" at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt.
Change in ArI = Month 6 index - Baseline index. The Arousal Index is a measurement used to indicate the number of times per hour of sleep that sleep is disrupted.
Outcome measures
| Measure |
Treatment Group
n=58 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
n=73 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
|---|---|---|
|
Arousal Index (ArI) Change From Baseline at 6 Months
|
-20.2 Events/hour
Interval -25.2 to -15.2
|
-5.0 Events/hour
Interval -9.2 to -0.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to "off" at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt.
Change in REM = Month 6 percentage - Baseline percentage. Rapid Eye Movement (REM) is a sleep stage. A higher percentage of sleep in REM is a measure of better sleep quality.
Outcome measures
| Measure |
Treatment Group
n=58 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
n=73 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
|---|---|---|
|
Rapid Eye Movement (REM) Sleep Change From Baseline at 6 Months
|
1.8 percentage of sleep
Interval -0.3 to 4.0
|
-0.6 percentage of sleep
Interval -2.4 to 1.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to "off" at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt. Note: 1 Control subject did not provide a response and is excluded from analysis.
The proportion of subjects with a "moderate" or "marked" improvement in the Patient Global Assessment from baseline to the 6 month visit
Outcome measures
| Measure |
Treatment Group
n=58 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
n=72 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
|---|---|---|
|
The Proportion of Participants Experiencing a Marked or Moderate Improvement in Patient Global Assessment at 6 Months
|
35 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to "off" at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt.
Change in ODI4 = Month 6 index - Baseline index. The Oxygen Desaturation Index 4% is a measurement of the number of times per hour of sleep that the blood's oxygen level drops ≥4%.
Outcome measures
| Measure |
Treatment Group
n=58 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
n=73 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
|---|---|---|
|
Oxygen Desaturation Index 4% (ODI4) Change From Baseline at 6 Months
|
-19.1 Events/hour
Interval -23.9 to -14.3
|
3.6 Events/hour
Interval -0.5 to 7.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to "off" at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt.
Change in ESS = Month 6 score - Baseline score. The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.
Outcome measures
| Measure |
Treatment Group
n=58 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy and remedē System therapy.
|
Control Group
n=73 Participants
Subjects implanted with the remedē System device who receive optimal medical therapy alone (remedē System inactive through 6 months).
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS) Change From Baseline at 6 Months
|
-3.6 units on a scale
Interval -5.1 to -2.1
|
0.1 units on a scale
Interval -0.9 to 1.2
|
Adverse Events
Pooled Group
Serious events: 74 serious events
Other events: 53 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Pooled Group
n=151 participants at risk
The study protocol pre-specified that randomized groups be combined to assess safety. All subjects were implanted with the remedē System device and received optimal medical therapy. The Treatment group had received 12 months active therapy and Control had received 6 months active therapy.
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
HEART FAILURE
|
10.6%
16/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
SUSTAINED VENTRICULAR TACHY ARRHYTHMIA
|
7.3%
11/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.3%
5/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
AORTIC VALVE DISEASE
|
2.0%
3/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
2.0%
3/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
COMPLICATION OF HEART FAILURE THERAPY
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
COMPLICATION OF CARDIAC SURGERY
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
INAPPROPRIATE ICD SHOCK
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
MITRAL VALVE DISEASE
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
RIGHT HEART PERFORATION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Cardiac disorders
SUDDEN DEATH
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Endocrine disorders
DIABETIC KETOACIDOSIS
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Endocrine disorders
DIABETIC TOE
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
Gastrointestinal disorders
COLONIC PERFORATION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Gastrointestinal disorders
DIVERTICULITIS
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Gastrointestinal disorders
GASTROINTESTINAL BLEED SECONDARY TO WARFARIN
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Gastrointestinal disorders
GASTROPARESIS
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Gastrointestinal disorders
PERFORATED BOWEL
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
IMPENDING POCKET EROSION
|
2.0%
3/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
IMPLANT SITE INFECTION
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
STIMULATION LEAD DISLODGEMENT (REMEDE SYSTEM)
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
ABDOMINAL DISCOMFORT
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
ALTERED MENTAL STATUS
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
CONCOMITANT DEVICE INTERACTION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
DEGENERATIVE JOINT DISEASE
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
ELECTIVE EXPLANT OF REMEDE SYSTEM
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
EXTRA-RESPIRATORY STIMULATION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
FLU LIKE SYMPTOMS
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
ICD LEAD FAILURE
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
IMPLANT SITE HEMATOMA
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
SINUS INFECTION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
STIMULATION LEAD COMPONENT FAILURE (REMEDE SYSTEM)
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
STIMULATION LEAD DISPLACEMENT (REMEDE SYSTEM)
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Infections and infestations
SEPSIS
|
2.0%
3/151 • Implant through 12 Months post therapy initiation visit window
|
|
Infections and infestations
PNEUMONIA
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
Infections and infestations
BLADDER INFECTION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Infections and infestations
BRONCHIAL INFECTION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Infections and infestations
CELLULITIS
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Infections and infestations
DIABETIC FOOT INFECTION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Infections and infestations
ENDOCARDITIS INFECTIVE
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Infections and infestations
ICD IMPLANT SITE INFECTION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Infections and infestations
LEG CELLULITIS
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Injury, poisoning and procedural complications
FRACTURE
|
2.0%
3/151 • Implant through 12 Months post therapy initiation visit window
|
|
Injury, poisoning and procedural complications
AORTIC INJURY
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Injury, poisoning and procedural complications
INTRAOPERATIVE NEUROLOGICAL INJURY
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Investigations
ELEVATED TRANSAMINASE
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
Musculoskeletal and connective tissue disorders
BICEP TENDON TEAR
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Musculoskeletal and connective tissue disorders
MENISCUS TEAR
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLOSIS
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CARCINOMA
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Nervous system disorders
STROKE
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
Nervous system disorders
AMNESIA
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Nervous system disorders
HEADACHE
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Nervous system disorders
SEIZURE
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Nervous system disorders
TRANSIENT ISCHEMIC ATTACKS
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Renal and urinary disorders
URINARY TRACT STENOSIS
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Surgical and medical procedures
CRT-D IMPLANT
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Surgical and medical procedures
CYCLOPHOTOCOAGULATION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Surgical and medical procedures
DRUG ELUTING STENT
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Surgical and medical procedures
ICD GENERATOR AND RV LEAD REPLACEMENT
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Surgical and medical procedures
ICD IMPLANT
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Surgical and medical procedures
LEFT SUBTALAR JOINT ARTHRODESIS, HARDWARE REMOVAL AND BONE GRAFTING
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
|
Vascular disorders
HYPOTENSION
|
1.3%
2/151 • Implant through 12 Months post therapy initiation visit window
|
|
Vascular disorders
PULMONARY EMBOLISM
|
0.66%
1/151 • Implant through 12 Months post therapy initiation visit window
|
Other adverse events
| Measure |
Pooled Group
n=151 participants at risk
The study protocol pre-specified that randomized groups be combined to assess safety. All subjects were implanted with the remedē System device and received optimal medical therapy. The Treatment group had received 12 months active therapy and Control had received 6 months active therapy.
|
|---|---|
|
General disorders
DIAPHRAGMATIC STIMULATION DISCOMFORT
|
25.2%
38/151 • Implant through 12 Months post therapy initiation visit window
|
|
General disorders
EXTRA-RESPIRATORY STIMULATION
|
9.3%
14/151 • Implant through 12 Months post therapy initiation visit window
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.3%
11/151 • Implant through 12 Months post therapy initiation visit window
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place