Purpose

The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria

1. Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep
study scored by a local sleep laboratory. It is strongly recommended that a patient
have a diagnostic PSG within 12 months of the expected implant date documenting
moderate to severe CSA.

2. Age 18 years or older

3. Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
informed consent

4. In the opinion of the investigator, subject is willing and able to comply with the
protocol.

5. Not currently enrolled in another investigational study or registry that would
directly interfere with the current study, except if the subject is participating in
a mandatory government registry, or a purely observational registry with no
associated treatments. Each instance should be brought to the attention of the
sponsor to determine eligibility.

6. In the opinion of the Investigator, life expectancy exceeds one year.

7. The subject is not pregnant or planning to become pregnant.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Respicardia, Inc.

Study Contact

Kimberly Guilbault
260-348-9035
kim.guilbault@zoll.com

Detailed Description

This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the remedē System. At least 500 subjects will be successfully implanted at approximately 50 sites in the United States and Europe.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.