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

Sleep Apnea Clinical Trial

— TREAT-CSA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02577445
• Other study ID #: NVNS03
• Status: Terminated
• Phase: N/A
• First received: September 25, 2015
• Last updated: April 5, 2017
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: April 2017
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 remede system / implanted with remede system

Implant Exclusion Criteria:

• Patients meeting the criteria as referred to in the latest version of the implant manual

Related Conditions & MeSH terms

• Apnea
• Central Sleep Disordered Breathing
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Locations

Country	Name	City	State
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
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital de Monteprincipe	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
LivaNova	Respicardia, Inc.

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)