Trial Outcomes & Findings for The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice (NCT NCT02577445)
NCT ID: NCT02577445
Last Updated: 2017-04-06
Results Overview
Collect short and long term clinical data on safety of the remede system implanted in daily practice. This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient.
TERMINATED
31 participants
From implant up to 5 years (collected until 24 month FU)
2017-04-06
Participant Flow
Participant milestones
| Measure |
CSA Patients NOT Implanted With remedē System
For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
|
CSA Patients With remedē System
For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
Patients will be asked to complete quality of life questionnaires at baseline and during follow-up visits.
Patients will be evaluated at the time of therapy activation which may be followed by one or more titration visits. Patient follow-ups will be programmed at 6 and 12 months, and yearly, up to 5 years post-implant, until the last patients reach their 2-year follow-up.
Echocardiogram for patients with reduced ejection fraction (≤ 45%) and follow-up respiratory polygraphy are considered standard of care, however, to ensure sufficient data, related to the study objectives, are being collected, baseline and 12-months echocardiogram for a subgroup of patients and respiratory polygraphy at 12-month follow-up for all patients must be done when participating in this study:
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice
Baseline characteristics by cohort
| Measure |
CSA Patients NOT Implanted With remedē® System
n=14 Participants
For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
|
CSA Patients With remedē System
n=17 Participants
For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
69.2 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From implant up to 5 years (collected until 24 month FU)Population: Viewing the limited amount of data at early study termination, the data should be interpreted with caution.
Collect short and long term clinical data on safety of the remede system implanted in daily practice. This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient.
Outcome measures
| Measure |
CSA Patients With remedē System
n=17 Participants
For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
|
CSA Patients With remedē System
For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
|
|---|---|---|
|
Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
Serious Adverse Events
|
6 Participants
|
—
|
|
Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
Deaths
|
0 Participants
|
—
|
|
Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
Serious Adverse Device Effects
|
3 Participants
|
—
|
|
Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
Stimulation complaints
|
1 Participants
|
—
|
|
Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
Cardiovascular events
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 months post-implantPopulation: A complete dataset is only available for 1 patient and due to confidentiality reasons for this 1 patient we prefer not to present this data.
Evaluate changes in sleep study results at 12 months compared to baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-implantPopulation: No data available on Quality of Life questionnaires; no patient completed the questionnaires at baseline AND at the 12M/24M follow-up at the time of premature study stop.
Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months post implantPopulation: No data available; no patient had completed a 12 months echo prior to the premature study stop
Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years (collected until 6M FU)Population: No conclusion can be drawn on all-cause mortality and all-cause hospitalization rates for this group of patients;only 3 subjects diagnosed with CSA (not implanted) reached the 6M FU at the time of study termination. No deaths and/or hospitalizations had been reported in this subject group at the time of study termination.No 12M data is available.
Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system
Outcome measures
| Measure |
CSA Patients With remedē System
n=14 Participants
For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
|
CSA Patients With remedē System
For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
|
|---|---|---|
|
Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea
hospitalizations
|
0 Participants
|
—
|
|
Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea
all cause mortality
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: screeningCharacterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed.
Outcome measures
Outcome data not reported
Adverse Events
CSA Patients NOT Implanted With remedē® System
CSA Patients With remedē System
Serious adverse events
| Measure |
CSA Patients NOT Implanted With remedē® System
n=14 participants at risk
For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
|
CSA Patients With remedē System
n=17 participants at risk
For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
|
|---|---|---|
|
Renal and urinary disorders
Acute Reneal Failure
|
0.00%
0/14
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Cardiac Decompensation
|
0.00%
0/14
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Cardiac/cardiorespiratory arrest
|
0.00%
0/14
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Other cardiac disorders
|
0.00%
0/14
|
17.6%
3/17 • Number of events 4
|
|
Product Issues
Lead Dislocation
|
0.00%
0/14
|
17.6%
3/17 • Number of events 3
|
Other adverse events
| Measure |
CSA Patients NOT Implanted With remedē® System
n=14 participants at risk
For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
|
CSA Patients With remedē System
n=17 participants at risk
For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
|
|---|---|---|
|
General disorders
Diaphragm stimulation discomfort
|
0.00%
0/14
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Cardiac decompensation
|
0.00%
0/14
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
beginning liver insufficiency
|
0.00%
0/14
|
5.9%
1/17 • Number of events 1
|
|
Product Issues
Lead Dislocation
|
0.00%
0/14
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
atrial arrhythmia
|
0.00%
0/14
|
5.9%
1/17 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The legal manufacturer of the medical device, Respicardia, shall be the owner of the Clinical study data including any results, and Respicardia shall have the right to control the publication timing, content and method for any public disclosure of the clinical study data. Respicardia's prior written approval must be obtained prior to any publication or disclosure of Clinical study data or results by Sponsor or Institution.
- Publication restrictions are in place
Restriction type: OTHER