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

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

1. to collect data in order to get a better understanding of the characteristics and/or symptoms related to central sleep apnea
2. to collect safety information of all patients diagnosed with central sleep apnea
3. 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.

Primary outcomes

• Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. [From implant up to 5 years (collected until 24 month FU)]: 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.

Secondary outcomes

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

Other outcomes

• Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea [screening]: Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. (Primary), Count of participants, Participants: CSA Patients With remedē System 6
• Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline (Secondary)
• Impact on Quality of Life Compared to Baseline (Secondary)
• Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline (Secondary)
• Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea (Secondary), Count of participants, Participants: CSA Patients NOT Implanted With remedē® System 0
• Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea (Other pre specified)

Adverse events

Serious adverse events by term

Other adverse events by term

Limitations and caveats: Due to the early study termination, the amount of collected data was inconclusive at the time of early study termination to draw any conclusion on the study objectives.

• Christoph Stellbrink, Principal investigator, Bielefeld-Klinikum
• Stefan Anker, Principal investigator, Herzzentrum Göttingen