Trial Outcomes & Findings for Post Approval Study of the remedē System (NCT NCT03425188)
NCT ID: NCT03425188
Last Updated: 2021-04-22
Results Overview
Assessment of survival in subjects with moderate to severe central sleep apnea being treated with the remedē System. The 5-year survival rate was estimated from Kaplan-Meier anlaysis, using time from implant to death, study exit or last contact. This analysis used all subjects enrolled in the original remede System Pivotal Trial.
Recruitment status
COMPLETED
Target enrollment
53 participants
Primary outcome timeframe
Through 5 years
Results posted on
2021-04-22
Participant Flow
151 subjects enrolled in the original pivotal trial of the remede system. 94 were ongoing at the time of trial closure and therefore eligible to participate in this continuation post approval study. Pivotal trial sites with subjects ongoing at the time of study closure were invited to participate in this long-term continuation study. Subjects needed to re-consent to participate. Due to sites or subjects declining participation, not all subjects participated in this continuation study.
Participant milestones
| Measure |
Treatment
Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study. This is a subset of the 151 subjects enrolled in the original pivotal trial of the remede System.
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|---|---|
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Overall Study
STARTED
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53
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Overall Study
COMPLETED
|
52
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
Treatment
Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study. This is a subset of the 151 subjects enrolled in the original pivotal trial of the remede System.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Post Approval Study of the remedē System
Baseline characteristics by cohort
| Measure |
Treatment
n=53 Participants
Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study
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|---|---|
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Age, Continuous
|
63 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Heart failure
|
29 Participants
n=5 Participants
|
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Apnea Hypopnea Index
|
41 events/hour
n=5 Participants
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|
Epworth Sleepiness Scale
|
12 units on a scale
n=5 Participants
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PRIMARY outcome
Timeframe: Through 5 yearsPopulation: All 151 subjects enrolled in the remedē System Pivotal Trial (NCT01816776) underwent an implant attempt and are included in this analysis. Longer term follow-up data from the subset of pivotal trial subjects enrolled in this post approval study was combined with the data from the pivotal trial for this analysis.
Assessment of survival in subjects with moderate to severe central sleep apnea being treated with the remedē System. The 5-year survival rate was estimated from Kaplan-Meier anlaysis, using time from implant to death, study exit or last contact. This analysis used all subjects enrolled in the original remede System Pivotal Trial.
Outcome measures
| Measure |
Enrolled in Pivotal Trial
n=151 Participants
All subjects enrolled in the remedē System Pivotal Trial underwent an implant attempt and are included in this analysis. Subjects randomized to the Treatment group had transvenous phrenic nerve stimulation therapy activated 1 month after implant and subjects randomized to the control group had therapy activated after approximately 7 months.
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|---|---|
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5-Year Survival Rate
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78 percentage of participants
Interval 71.0 to 85.0
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PRIMARY outcome
Timeframe: Through 5 yearsPopulation: All 151 subjects enrolled in the remedē System Pivotal Trial (NCT01816776) underwent an implant attempt and are included in this analysis. Longer term follow-up data from the subset of pivotal trial subjects enrolled in this post approval study was combined with the data from the pivotal trial for this analysis.
Assessment of long-term safety via a summary of anticipated or unanticipated device-related SAEs. Proportion of subjects experiencing a device related SAE through the time point of interest. This analysis combined data from the original pivotal trial and this post approval study.
Outcome measures
| Measure |
Enrolled in Pivotal Trial
n=151 Participants
All subjects enrolled in the remedē System Pivotal Trial underwent an implant attempt and are included in this analysis. Subjects randomized to the Treatment group had transvenous phrenic nerve stimulation therapy activated 1 month after implant and subjects randomized to the control group had therapy activated after approximately 7 months.
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|---|---|
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Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years
3 Years
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9 Participants
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Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years
5 Years
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12 Participants
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PRIMARY outcome
Timeframe: Through 3 and 5 yearsPopulation: All 151 subjects enrolled in the remedē System Pivotal Trial (NCT01816776) underwent an implant attempt and are included in this analysis. Longer term follow-up data from the subset of pivotal trial subjects enrolled in this post approval study was combined with the data from the pivotal trial for this analysis.
Assessment of the safety of the remedē System by evaluating anticipated or unanticipated therapy-related SAEs. Proportion of subjects experiencing a therapy related SAE through the time point of interest.
Outcome measures
| Measure |
Enrolled in Pivotal Trial
n=151 Participants
All subjects enrolled in the remedē System Pivotal Trial underwent an implant attempt and are included in this analysis. Subjects randomized to the Treatment group had transvenous phrenic nerve stimulation therapy activated 1 month after implant and subjects randomized to the control group had therapy activated after approximately 7 months.
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|---|---|
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Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years
3 Years
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4 Participants
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Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years
5 Years
|
4 Participants
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PRIMARY outcome
Timeframe: 5 yearsPopulation: Includes all subjects who had 5 year sleep study results who were receiving active therapy during the sleep study. This is a subgroup of subjects from the original pivotal trial who enrolled in this post approval study and had sleep study data available at 5 years.
Change in AHI = Year 5 index - Baseline index. The Apnea-Hypopnea Index is a measurement obtained from an overnight sleep study used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The events were scored according to the 2007 "American Academy of Sleep Medicine manual for the scoring of sleep and associated events: rules, terminology and technical specifications" (Iber, et. al).
Outcome measures
| Measure |
Enrolled in Pivotal Trial
n=43 Participants
All subjects enrolled in the remedē System Pivotal Trial underwent an implant attempt and are included in this analysis. Subjects randomized to the Treatment group had transvenous phrenic nerve stimulation therapy activated 1 month after implant and subjects randomized to the control group had therapy activated after approximately 7 months.
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|---|---|
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Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years
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-22 Events/hour
Interval -42.0 to -7.0
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PRIMARY outcome
Timeframe: 5 yearsPopulation: Includes all subjects who completed the ESS at 5 years. This is a subgroup of subjects from the original pivotal trial who enrolled in this post approval study and had data available at 5 years.
Change in ESS = Year 5 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 |
Enrolled in Pivotal Trial
n=51 Participants
All subjects enrolled in the remedē System Pivotal Trial underwent an implant attempt and are included in this analysis. Subjects randomized to the Treatment group had transvenous phrenic nerve stimulation therapy activated 1 month after implant and subjects randomized to the control group had therapy activated after approximately 7 months.
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|---|---|
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Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years
|
-3 units on a scale
Interval -8.0 to -1.0
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Adverse Events
Treatment
Serious events: 23 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=53 participants at risk
Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study
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|---|---|
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Cardiac disorders
HEART FAILURE
|
5.7%
3/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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Cardiac disorders
ACUTE CORONARY SYNDROME
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1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
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Cardiac disorders
ATRIAL FIBRILLATION
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1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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Cardiac disorders
CORONARY ARTERY DISEASE
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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Cardiac disorders
HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY
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1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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Cardiac disorders
SINUS BRADYCARDIA
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1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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Cardiac disorders
VENTRICULAR TACHYCARDIA
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1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
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Endocrine disorders
HYPOTHYROIDISM
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1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
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Gastrointestinal disorders
INGUINAL HERNIA
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1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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General disorders
IMPLANT SITE INFECTION
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1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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General disorders
INGROWN TOENAIL
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1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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General disorders
LEAD COMPONENT FAILURE
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1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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General disorders
LEAD DISLODGEMENT
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
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General disorders
LEAD DISPLACEMENT
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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General disorders
SIMULATION LEAD EXTRACTION
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
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General disorders
STIMULATION LEAD PLACEMENT
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Infections and infestations
ABSCESS
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
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Infections and infestations
APPENDICITIS
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Infections and infestations
SEPSIS
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Infections and infestations
WOUND INFECTION
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Injury, poisoning and procedural complications
ROTATOR CUFF TEAR
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CARCINOMA
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Nervous system disorders
STROKE
|
5.7%
3/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Nervous system disorders
PARESTHESIA
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Nervous system disorders
SYNCOPE
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Nervous system disorders
TRANSIENT ISCHEMIC ATTACKS
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Surgical and medical procedures
PAIN PUMP IMPLANT
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
|
Vascular disorders
HYPERTENSION
|
1.9%
1/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
Other adverse events
| Measure |
Treatment
n=53 participants at risk
Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study
|
|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
5.7%
3/53 • The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Without prior written agreement of the Sponsor, Research Institution and site Principal Investigator agree not to publish results for at least 1 year from finalization of the study database, after which time site Principal Investigator may publish or submit for publication a Manuscript without further delay subject to the sponsor having 60 days to review the proposed publication and additional 90 day provision if intellectual property is at risk to allow time for submitting patent applications.
- Publication restrictions are in place
Restriction type: OTHER