The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice

Study Overview
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Brief Summary
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The aim of this post market study is to assess the impact of sleep-disordered breathing on the well-being of patients according to the treatment chosen, i.e. with or without implantation of the remedē® system to treat sleep-disordered breathing.

Detailed Description
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The sponsor of this study, LivaNova, has a partnership with Respicardia, Inc who has developed a battery-powered implantable device that treats central sleep apnea. The device is used with a lead that delivers the stimulation therapy which causes the patient to breathe with a regular rhythm and an optional lead that senses breathing. This combination is called the remedē® system. The aim of this study is to collect data in order to get a better understanding of the characteristics and/or symptoms related to central sleep apnea to collect safety information of all patients diagnosed with central sleep apnea to obtain additional short and lang term information on the safety and performance of the remedē® system, including an evaluation if there's an impact on the quality of life of patients treated with the the remedē® system in daily practice. The information obtained from this study may provide better insight on the symptoms related to central sleep apnea, risk factors related to central sleep apnea therapy and use of the remedē® system which may help to treat other patients with potential sleep disordered breathing more appropriately. Approximately 300 patients (to be) implanted with the remedē® system will participate in this study at approximately 40 sites in Europe. For this purpose the investigators aim to screen approximately 1500 patients with sleep-disordered breathing. Also patients diagnosed with central sleep apnea, but not receiving the device will be followed through phone calls for 2 years.

Official Title
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The remedē® System (Respiratory Rhythm Management™ Device) for the Treatment of Central Sleep Apnea in Daily Practice

Conditions
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Sleep Apnea, Central Sleep Disordered Breathing

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients screened for sleep disordered breathing Age > 18 years Signed Ethics Committee approved informed consent Implant Inclusion criteria Diagnosis of moderate to severe central sleep apnea and referred for implant of the remedē system / implanted with remedē system Implant Exclusion Criteria: Patients meeting the criteria as referred to in the latest version of the implant manual

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CSA patients without remedē system<br>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<br>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: | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. | 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. | From implant up to 5 years (collected until 24 month FU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline | Evaluate changes in sleep study results at 12 months compared to baseline | 12 months post-implant | 
| Impact on Quality of Life Compared to Baseline | Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients | Up to 5 years post-implant | 
| Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline | Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline | 12 months post implant | 
| Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea | Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system | Up to 2 years (collected until 6M FU) |