Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT03884660
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-24
First Post:
2019-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
remedē System Therapy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020182', 'term': 'Sleep Apnea, Central'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood Sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2019-03-19', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate changes in daytime sleepiness through 12 months', 'timeFrame': '12 months', 'description': 'Epworth Sleepiness Scale (ESS) change from baseline to 12-month visit'}, {'measure': 'Evaluate changed in quality of life (QOL) through 12 months', 'timeFrame': '12 months', 'description': 'Quality of life assessment including the following:\n\n* Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline at 12 months (HF subgroup only)\n* PROMIS-29 questionnaire change from baseline at 12, months\n* Patient Global Assessment (PGA) at 12 months'}, {'measure': 'Evaluate changes in left ventricular ejection fraction in the HF subgroup after 12 months of therapy', 'timeFrame': '12 months', 'description': 'Change in left ventricular ejection fraction based on echocardiographic assessment in the HF subgroup from baseline to 12 months.'}], 'primaryOutcomes': [{'measure': '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', 'timeFrame': '5 years', 'description': 'Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy'}, {'measure': 'Evaluate changes in sleep disordered breathing metrics after 12 months of therapy', 'timeFrame': '12 months', 'description': '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%'}], 'secondaryOutcomes': [{'measure': 'Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy', 'timeFrame': '5 years', 'description': 'Proportion of subjects with non-serious AEs related to the remedē System implant procedure, device or delivered therapy'}, {'measure': 'Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy', 'timeFrame': '36 and 60 months', 'description': '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%'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Central Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '36116293', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': '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.\n2. Age 18 years or older\n3. Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent\n4. In the opinion of the investigator, subject is willing and able to comply with the protocol.\n5. 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.\n6. In the opinion of the Investigator, life expectancy exceeds one year.\n7. The subject is not pregnant or planning to become pregnant.'}, 'identificationModule': {'nctId': 'NCT03884660', 'acronym': 'rēST', 'briefTitle': 'remedē System Therapy Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Respicardia, Inc.'}, 'officialTitle': 'Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System', 'orgStudyIdInfo': {'id': 'CIP1393'}}, 'armsInterventionsModule': {'interventions': [{'name': 'remede System', 'type': 'DEVICE', 'description': 'Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Heart Rhythm Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'The University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado- Anschutz', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Central Florida Pulmonary Group', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Midtown Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '49519', 'city': 'Wyoming', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health West', 'geoPoint': {'lat': 42.91336, 'lon': -85.70531}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Mid America Heart Institute", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '07652', 'city': 'Paramus', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Valley Hospital', 'geoPoint': {'lat': 40.94454, 'lon': -74.07542}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico Heart Institute - Lovelace Medical Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital-Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health - Charlotte', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Medicine Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Heart Institute', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Monument Health', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott and White - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '1061AE', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'OLVG Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '4818 CK', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Longresearch', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '7512 KZ', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}], 'overallOfficials': [{'name': 'Kathy McPherson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ZOLL Respicardia, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Respicardia, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}