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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source Respicardia, Inc.
Contact Kimberly Guilbault
Phone 260-348-9035
Email kim.guilbault@zoll.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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. At least 500 subjects will be successfully implanted at approximately 50 sites in the United States and Europe.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
remede System
Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Respicardia, Inc.

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

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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