Central Sleep Apnea
Conditions
Brief summary
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
Detailed description
This Post Approval Study is a multi-center, prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System from the remedē System Pivotal Trial. Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible. An individual subject's participation is expected to continue to five years post remedē System implant.
Interventions
None listed
Sponsors
Respicardia, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who were previously implanted with the remedē System and participated in the remedē System Pivotal Trial * In the investigator's opinion, willing and able to comply with all study requirements * Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent (including Health Insurance Portability and Accountability Act \[HIPAA\] authorization in the US)
Exclusion criteria
* There are no criteria by which a subject would be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-Year Survival Rate | Through 5 years | 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. |
| Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years | Through 5 years | 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. |
| Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years | Through 3 and 5 years | 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. |
| Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years | 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). |
| Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years | 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. |
Countries
Germany, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 11 |
| Apnea Hypopnea Index | 41 events/hour |
| Epworth Sleepiness Scale | 12 units on a scale |
| Heart failure | 29 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 3 / 53 |
| serious Total, serious adverse events | 23 / 53 |
Outcome results
Primary
5-Year Survival Rate
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.
Time frame: Through 5 years
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enrolled in Pivotal Trial | 5-Year Survival Rate | 78 percentage of participants |
Primary
Apnea-Hypopnea Index (AHI) Change From Baseline 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).
Time frame: 5 years
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enrolled in Pivotal Trial | Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years | -22 Events/hour |
Primary
Epworth Sleepiness Scale (ESS) Change From Baseline 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.
Time frame: 5 years
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enrolled in Pivotal Trial | Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years | -3 units on a scale |
Primary
Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years
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.
Time frame: Through 5 years
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled in Pivotal Trial | Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years | 3 Years | 9 Participants |
| Enrolled in Pivotal Trial | Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years | 5 Years | 12 Participants |
Primary
Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years
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.
Time frame: Through 3 and 5 years
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled in Pivotal Trial | Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years | 3 Years | 4 Participants |
| Enrolled in Pivotal Trial | Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years | 5 Years | 4 Participants |