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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.
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. Approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the United States and Europe. A sub-study involving the WatchPAT device will be performed in a subset of sites.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remede System | Device | Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety of the remedē 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 remedē System implant procedure, device or delivered therapy | 5 years |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy | Proportion of subjects with non-serious AEs related to the remedē System implant procedure, device or delivered therapy | 5 years |
| Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate changes in daytime sleepiness through 12 months | Epworth Sleepiness Scale (ESS) change from baseline to 12-month visit | 12 months |
| Evaluate changed in quality of life (QOL) through 12 months | Quality of life assessment including the following:
|
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Subjects who are determined to be candidates, independent of this research study, to receive a de novo commercial implant of the remedē System are eligible for inclusion in this trial, subject to the entry criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Kathy McPherson | ZOLL Respicardia, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Arizona Heart Rhythm Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36116293 | Derived | Goldberg LR, Fox H, Stellbrink C, Bozkurt B, Boehmer JP, Mora JI, Doshi R, Morgenthaler TI, Levy WC, Meyer TE, McKane SW, Germany R; remede System Therapy Study Group. Design of the remede System Therapy (reST) study: A prospective non-randomized post-market study collecting clinical data on safety and effectiveness of the remede system for the treatment of central sleep apnea. Sleep Med. 2022 Dec;100:238-243. doi: 10.1016/j.sleep.2022.08.026. Epub 2022 Sep 6. |
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Blood Sample
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 |
| 12 months |
| 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 |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| HonorHealth | Scottsdale | Arizona | 85258 | United States |
| The University of California San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado- Anschutz | Aurora | Colorado | 80045 | United States |
| University of Colorado Health | Fort Collins | Colorado | 80528 | United States |
| Central Florida Pulmonary Group | Orlando | Florida | 32803 | United States |
| Emory University Midtown Hospital | Atlanta | Georgia | 30329 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| University of Michigan Health West | Wyoming | Michigan | 49519 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| St. Luke's Mid America Heart Institute | Kansas City | Missouri | 64111 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| New Mexico Heart Institute - Lovelace Medical Center | Albuquerque | New Mexico | 87102 | United States |
| Northwell Health | New Hyde Park | New York | 11040 | United States |
| New York Presbyterian Hospital-Weill Cornell Medicine | New York | New York | 10065 | United States |
| Novant Health - Charlotte | Charlotte | North Carolina | 28204 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| The Ohio State Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | United States |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Monument Health | Rapid City | South Dakota | 57701 | United States |
| Baylor Scott and White - Dallas | Dallas | Texas | 75246 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| OLVG Amsterdam | Amsterdam | 1061AE | Netherlands |
| Amphia Longresearch | Breda | 4818 CK | Netherlands |
| Medisch Spectrum Twente | Enschede | 7512 KZ | Netherlands |
| ID | Term |
|---|---|
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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