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

Terminated

Conditions: Central Sleep Disordered Breathing
Sleep Apnea

Registration Number: NCT02577445

Lead Sponsor: LivaNova

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 31

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10): St. Vincenz-Krankenhaus
🇩🇪
Paderborn, Germany
Hospital Universitario de Burgos
🇪🇸
Burgos, Spain
Herz- und Diabeteszentrum Bad Oeynhausen
🇩🇪
Bad Oeynhausen, Germany
Albertinen Krankenhaus
🇩🇪
Hamburg, Germany
Klinikum Bielefeld Mitte
🇩🇪
Bielefeld, Germany
Alice Hospital
🇩🇪
Darmstadt, Germany
Klinikum Lünen - St Marien Hospital
🇩🇪
Lünen, Germany
Hospital Infanta Cristina
🇪🇸
Badajoz, Spain
Hospital de Monteprincipe
🇪🇸
Madrid, Spain
Universitaetsklinikum Schleswig Holstein
🇩🇪
Kiel, Germany