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

NCT02577445 | Terminated Results DMC

• 1 other identifier: NVNS03
• Study Type: observational
• Target: 31
• Locations: 2 countries
• Sites: 10

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.

Conditions

Sleep Apnea; Central Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline

  12 months post-implant

• Impact on Quality of Life Compared to Baseline

  Up to 5 years post-implant

• Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline

  12 months post implant

• 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)

Other Outcomes (1)

• Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea

  screening

Study Arms (2)

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:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with central sleep apnea

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• LivaNova: lead
• Respicardia, Inc.: collaborator

Study Sites (10)

Herz- und Diabeteszentrum Bad Oeynhausen

Bad Oeynhausen, Germany

Location

Klinikum Bielefeld Mitte

Bielefeld, Germany

Location

Alice Hospital

Darmstadt, Germany

Location

Albertinen Krankenhaus

Hamburg, Germany

Location

Universitaetsklinikum Schleswig Holstein

Kiel, Germany

Location

Klinikum Lünen - St Marien Hospital

Lünen, Germany

Location

St. Vincenz-Krankenhaus

Paderborn, Germany

Location

Hospital Infanta Cristina

Badajoz, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital de Monteprincipe

Madrid, Spain

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

Due to the early study termination, the amount of collected data was inconclusive at the time of early study termination to draw any conclusion on the study objectives.

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Livanova

renske.dezwaef@livanova.com

0032498644704

Study Officials

• Christoph Stellbrink

  Bielefeld-Klinikum

  PRINCIPAL INVESTIGATOR

• Stefan Anker

  Herzzentrum Göttingen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: October 16, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 6, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-04

Locations

ES (3); DE (7)