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remedē System Therapy Study
Sponsor: Respicardia, Inc.
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.
Official title: Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
225
Start Date
2019-06-18
Completion Date
2030-12-30
Last Updated
2025-07-24
Healthy Volunteers
No
Conditions
Interventions
remede System
Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.
Locations (32)
Banner University Medical Center
Phoenix, Arizona, United States
Arizona Heart Rhythm Center
Phoenix, Arizona, United States
HonorHealth
Scottsdale, Arizona, United States
The University of California San Francisco
San Francisco, California, United States
University of Colorado- Anschutz
Aurora, Colorado, United States
University of Colorado Health
Fort Collins, Colorado, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
Emory University Midtown Hospital
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Michigan Health West
Wyoming, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Luke's Mid America Heart Institute
Kansas City, Missouri, United States
The Valley Hospital
Paramus, New Jersey, United States
New Mexico Heart Institute - Lovelace Medical Center
Albuquerque, New Mexico, United States
Northwell Health
New Hyde Park, New York, United States
New York Presbyterian Hospital-Weill Cornell Medicine
New York, New York, United States
Novant Health - Charlotte
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
The Ohio State Wexner Medical Center
Columbus, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Monument Health
Rapid City, South Dakota, United States
Baylor Scott and White - Dallas
Dallas, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
OLVG Amsterdam
Amsterdam, Netherlands
Amphia Longresearch
Breda, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands