remedē System Therapy Study

Central Sleep Apnea Clinical Trial

— reST  

Official title:

Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03884660
• Other study ID #: CIP1393
• Status: Recruiting
• Start date: June 18, 2019
• Est. completion date: June 30, 2032

Study information

• Verified date: April 2024
• Source: Respicardia, Inc.
• Contact: Kimberly Guilbault
• Phone: 260-348-9035
• Email: kim.guilbault[@]zoll.com
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Central Sleep Apnea
• Sleep Apnea, Central

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	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