respiratory arrest during sleep apnea
Conditions
Interventions
 
remed*®-System 
Sponsors
ZOLL Respicardia Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: The subject is pregnant or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoint: Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remed* System implant procedure, device or delivered therapy. Efficacy endpoint: Change from baseline to 12-month visit for the following sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4), percent of sleep with oxygen saturation <90% | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoint: Proportion of subjects with non-serious AEs related to the remed* System implant procedure, device or delivered therapy Efficacy endpoints: - Change from baseline to 36- and 60-month visits for the following sleep metrics during an at home sleep apnea test (HSAT): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4), percent of sleep with oxygen saturation <90% - Epworth Sleepiness Scale (ESS) change from baseline to 12-month visit. - Quality of life assessment including the following: Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline at 12 months (HF subgroup only), PROMIS-29 questionnaire change from baseline at 12 months, Patient Global Assessment (PGA) at 12 months - Change in left ventricular ejection fraction based on echocardiographic assessment in the HF subgroup from baseline to 12 months. | — |
Countries
Netherlands, United States
Contacts
Public ContactChief Medical Officer
ZOLL Respicardia Inc.
Outcome results
None listed