Prospective non-randomised post-market study collecting clinical data on safety and effectiveness of the remed*®-System

Phase 4

Recruiting

Conditions: respiratory arrest during sleep
sleep apnea
10019280
10040998

Registration Number: NL-OMON53885

Lead Sponsor: Zoll Respicardia Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

-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.
-Age 18 years or older
-Signed approved informed consent
-In the opinion of the investigator, subject is willing and able to comply with
the protocol.
-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.
-In the opinion of the Investigator, life expectancy exceeds one year.
-The subject is not pregnant or planning to become pregnant.

Exclusion Criteria

The subject is pregnant or planning to become pregnant

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety endpoint: Proportion of subjects with peri-operative and long-term<br /><br>serious adverse events (SAEs) related to the remed* System implant procedure,<br /><br>device or delivered therapy.<br /><br><br /><br>Efficacy endpoint: Change from baseline to 12-month visit for the following<br /><br>sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index<br /><br>(AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4), percent<br /><br>of sleep with oxygen saturation <90%</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety endpoint: Proportion of subjects with non-serious AEs related to the<br /><br>remed* System implant procedure, device or delivered therapy<br /><br><br /><br>Efficacy endpoints:<br /><br>- Change from baseline to 36- and 60-month visits for the following sleep<br /><br>metrics during an at home sleep apnea test (HSAT): apnea hypopnea index (AHI),<br /><br>central apnea index (CAI), oxygen desaturation index 4% (ODI4), percent of<br /><br>sleep with oxygen saturation <90%<br /><br>- Epworth Sleepiness Scale (ESS) change from baseline to 12-month visit.<br /><br>- Quality of life assessment including the following: Kansas City<br /><br>Cardiomyopathy Questionnaire (KCCQ) change from baseline at 12 months (HF<br /><br>subgroup only), PROMIS-29 questionnaire change from baseline at 12 months,<br /><br>Patient Global Assessment (PGA) at 12 months<br /><br>- Change in left ventricular ejection fraction based on echocardiographic<br /><br>assessment in the HF subgroup from baseline to 12 months.</p><br>