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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-10-31

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.

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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

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.

Conditions

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Sleep Apnea Central Sleep Disordered Breathing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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CSA patients without 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.

No interventions assigned to this group

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:

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients screened for sleep disordered breathing
* Age \> 18 years
* Signed Ethics Committee approved informed consent

* Diagnosis of moderate to severe central sleep apnea and referred for implant of the remedē system / implanted with remedē system