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Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
This Post Approval Study is a multi-center, prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System from the remedē System Pivotal Trial. Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible. An individual subject's participation is expected to continue to five years post remedē System implant.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Keck Medical Center of USC
Los Angeles, California, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Cooper Health System
Cherry Hill, New Jersey, United States
Novant Clinical Research Institute Forsyth Medical Center
Winston-Salem, North Carolina, United States
Start Date
June 28, 2018
Primary Completion Date
August 4, 2020
Completion Date
August 4, 2020
Last Updated
April 22, 2021
53
ACTUAL participants
Lead Sponsor
Respicardia, Inc.
NCT03621566
NCT06043830
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03421704