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

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ClinicalTrials.gov Identifier: NCT02577445
Recruitment Status : Terminated (Commercial distribution of the remedē System stopped by LivaNova.)
First Posted : October 16, 2015
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
Respicardia, Inc.
Information provided by (Responsible Party):
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.

Condition or disease
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
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The remedē® System (Respiratory Rhythm Management™ Device) for the Treatment of Central Sleep Apnea in Daily Practice
Study Start Date : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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:




Primary Outcome Measures :
  1. Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. [ Time Frame: 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 :
  1. Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline [ Time Frame: 12 months post-implant ]
    Evaluate changes in sleep study results at 12 months compared to baseline

  2. Impact on Quality of Life Compared to Baseline [ Time Frame: 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

  3. Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline [ Time Frame: 12 months post implant ]
    Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline

  4. Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea [ Time Frame: 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 Outcome Measures:
  1. Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea [ Time Frame: screening ]
    Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with central sleep apnea
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577445


Locations
Germany
Herz- und Diabeteszentrum Bad Oeynhausen
Bad Oeynhausen, Germany
Klinikum Bielefeld Mitte
Bielefeld, Germany
Alice Hospital
Darmstadt, Germany
Albertinen Krankenhaus
Hamburg, Germany
Universitaetsklinikum Schleswig Holstein
Kiel, Germany
Klinikum Lünen - St Marien Hospital
Lünen, Germany
St. Vincenz-Krankenhaus
Paderborn, Germany
Spain
Hospital Infanta Cristina
Badajoz, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital de Monteprincipe
Madrid, Spain
Sponsors and Collaborators
LivaNova
Respicardia, Inc.
Investigators
Principal Investigator: Christoph Stellbrink Bielefeld-Klinikum
Principal Investigator: Stefan Anker Herzzentrum Göttingen

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT02577445     History of Changes
Other Study ID Numbers: NVNS03
First Posted: October 16, 2015    Key Record Dates
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases