Central Sleep Apnea Clinical Trial
— reSTOfficial title:
Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System
NCT number | NCT03884660 |
Other study ID # | CIP1393 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 18, 2019 |
Est. completion date | June 30, 2032 |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | June 30, 2032 |
Est. primary completion date | June 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amphia Longresearch | Breda | |
United States | New Mexico Heart Institute - Lovelace Medical Center | Albuquerque | New Mexico |
United States | Emory University Midtown Hospital | Atlanta | Georgia |
United States | University of Colorado- Anschutz | Aurora | Colorado |
United States | St. Luke's Regional Medical Center | Boise | Idaho |
United States | Novant Health - Charlotte | Charlotte | North Carolina |
United States | University of Chicago | Chicago | Illinois |
United States | The Ohio State Wexner Medical Center | Columbus | Ohio |
United States | Baylor Scott and White - Dallas | Dallas | Texas |
United States | Ohio Sleep Medicine Institute | Dublin | Ohio |
United States | University of Colorado Health | Fort Collins | Colorado |
United States | East Carolina University | Greenville | North Carolina |
United States | Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | St. Luke's Mid America Heart Institute | Kansas City | Missouri |
United States | Baptist Health Lexington | Lexington | Kentucky |
United States | West Virginia University | Morgantown | West Virginia |
United States | Northwell Health | New Hyde Park | New York |
United States | New York Presbyterian Hospital-Weill Cornell Medicine | New York | New York |
United States | Central Florida Pulmonary Group | Orlando | Florida |
United States | The Valley Hospital | Paramus | New Jersey |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Arizona Heart Rhythm Center | Phoenix | Arizona |
United States | Banner University Medical Center | Phoenix | Arizona |
United States | Monument Health | Rapid City | South Dakota |
United States | Mayo Clinic | Rochester | Minnesota |
United States | The University of California San Francisco | San Francisco | California |
United States | HonorHealth | Scottsdale | Arizona |
United States | Oklahoma Heart Institute | Tulsa | Oklahoma |
United States | Novant Health Forsyth Medical Center | Winston-Salem | North Carolina |
United States | University of Michigan Health West | Wyoming | Michigan |
Lead Sponsor | Collaborator |
---|---|
Respicardia, Inc. |
United States, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Evaluate changes in daytime sleepiness through 12 months | Epworth Sleepiness Scale (ESS) change from baseline to 12-month visit | 12 months | |
Other | Evaluate changed in quality of life (QOL) through 12 months | 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 |
12 months | |
Other | Evaluate changes in left ventricular ejection fraction in the HF subgroup after 12 months of therapy | Change in left ventricular ejection fraction based on echocardiographic assessment in the HF subgroup from baseline to 12 months. | 12 months | |
Primary | Evaluate safety of the remede System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy | Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remede System implant procedure, device or delivered therapy | 5 years | |
Primary | Evaluate changes in sleep disordered breathing metrics after 12 months of therapy | 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) and percent of sleep with oxygen saturation <90% | 12 months | |
Secondary | Evaluate safety of the remede System by assessment of non-serious AE related to procedure, device or delivered therapy | Proportion of subjects with non-serious AEs related to the remede System implant procedure, device or delivered therapy | 5 years | |
Secondary | Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy | 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% | 36 and 60 months |
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