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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Entry Criteria:

• Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. It is recommended that a patient have a PSG within 12 months of the expected implant date documenting moderate to severe CSA.

• Age 18 years or older

• Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent

• In the opinion of the investigator, subject is willing and able to comply with the protocol.

• 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.

• In the opinion of the Investigator, life expectancy exceeds one year.

• The subject is not pregnant or planning to become pregnant.

Locations
United States
Arizona
Arizona Heart Rhythm Center
Recruiting
Phoenix
HonorHealth
Recruiting
Scottsdale
California
The University of California San Francisco
Recruiting
San Francisco
Colorado
University of Colorado- Anschutz
Recruiting
Aurora
University of Colorado Health
Recruiting
Fort Collins
Idaho
St. Luke's Regional Medical Center
Recruiting
Boise
Illinois
University of Chicago
Recruiting
Chicago
Kentucky
Baptist Health Lexington
Recruiting
Lexington
Michigan
Metro Health
Recruiting
Wyoming
Missouri
St. Luke's Mid America Heart Institute
Recruiting
Kansas City
North Carolina
Novant - Charlotte
Recruiting
Charlotte
Novant Health Forsyth Medical Center
Recruiting
Winston-salem
New Jersey
The Valley Hospital
Recruiting
Paramus
New York
Northwell Health
Not yet recruiting
New Hyde Park
New York Presbyterian Hospital-Weill Cornell Medicine
Recruiting
New York
Ohio
The Ohio State Wexner Medical Center
Recruiting
Columbus
Ohio Sleep Medicine Institute
Recruiting
Dublin
Oklahoma
Oklahoma Heart Institute
Recruiting
Tulsa
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Recruiting
Hershey
Hospital of the University of Pennsylvania
Recruiting
Philadelphia
South Dakota
Monument Health
Recruiting
Rapid City
Texas
Baylor Scott and White - Dallas
Recruiting
Dallas
Contact Information
Primary
Kimberly Guilbault
kim.guilbault@zoll.com
260-348-9035
Backup
Tsiry Rabemahefa
tsiry.rabemahefa@zoll.com
218-329-7356
Time Frame
Start Date: June 18, 2019
Estimated Completion Date: April 15, 2027
Participants
Target number of participants: 500
Related Therapeutic Areas
Sponsors
Leads: Respicardia, Inc.

This content was sourced from clinicaltrials.gov

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