Clinical trial NCT03884660: remedē System Therapy Study
Official title: Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Central Sleep Apnea
Lead sponsor: Respicardia, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
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
measure: Evaluate changes in sleep disordered breathing metrics after 12 months of therapy
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy
timeFrame: 5 years
measure: Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy
timeFrame: 36 and 60 months
Other outcomes:
measure: Evaluate changes in daytime sleepiness through 12 months
timeFrame: 12 months
measure: Evaluate changed in quality of life (QOL) through 12 months
timeFrame: 12 months
measure: Evaluate changes in left ventricular ejection fraction in the HF subgroup after 12 months of therapy
timeFrame: 12 months
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Heart Rhythm Center
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: San Francisco
country: United States
facility: The University of California San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado- Anschutz
state: Colorado
city: Fort Collins
country: United States
facility: University of Colorado Health
state: Colorado
city: Orlando
country: United States
facility: Central Florida Pulmonary Group
state: Florida
city: Atlanta
country: United States
facility: Emory University Midtown Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Wyoming
country: United States
facility: University of Michigan Health West
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Mid America Heart Institute
state: Missouri
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute - Lovelace Medical Center
state: New Mexico
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Cornell Medicine
state: New York
city: Charlotte
country: United States
facility: Novant Health - Charlotte
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State Wexner Medical Center
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Rapid City
country: United States
facility: Monument Health
state: South Dakota
city: Dallas
country: United States
facility: Baylor Scott and White - Dallas
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Amsterdam
country: Netherlands
facility: OLVG Amsterdam
city: Breda
country: Netherlands
facility: Amphia Longresearch
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
Study officials:
affiliation: ZOLL Respicardia, Inc.
name: Kathy McPherson
role: STUDY_DIRECTOR
References: