The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice (TREAT-CSA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Sleep Apnea; Central 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.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany
    • Herz- und Diabeteszentrum Bad Oeynhausen
  • Bielefeld, Germany
    • Klinikum Bielefeld Mitte
  • Darmstadt, Germany
    • Alice Hospital
  • Hamburg, Germany
    • Albertinen Krankenhaus
  • Kiel, Germany
    • Universitaetsklinikum Schleswig Holstein
  • Lünen, Germany
    • Klinikum Lünen - St Marien Hospital
  • Paderborn, Germany
    • St. Vincenz-Krankenhaus
• Spain
  • Badajoz, Spain
    • Hospital Infanta Cristina
  • Burgos, Spain
    • Hospital Universitario de Burgos
  • Madrid, Spain
    • Hospital de Montepríncipe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with central sleep apnea

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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:

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea	Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed.	screening

Collaborators and Investigators

• Sponsor: LivaNova
• Collaborators: Respicardia, Inc.
• Investigators: Principal Investigator: Christoph Stellbrink, Bielefeld-Klinikum; Principal Investigator: Stefan Anker, Herzzentrum Gottingen

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: September 25, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: NVNS03