Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post Approval Study of the remedē System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03425188
Recruitment Status : Enrolling by invitation
First Posted : February 7, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Respicardia, Inc.

Brief Summary:
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.

Condition or disease
Central Sleep Apnea

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 94 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Approval Study of the remedē System
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Group/Cohort
remedē System Subjects
Subjects who were implanted with the remedē System and actively followed as part of the remedē System Pivotal Trial at the time of study closure.



Primary Outcome Measures :
  1. Evaluate the survival rate [ Time Frame: Through 5 years ]
    Assessment of survival in subjects with moderate to severe central sleep apnea being treated with the remedē System

  2. Evaluate long-term three and five-year device-related Serious Adverse Events (SAEs) [ Time Frame: Through 5 years ]
    Assessment of long-term safety via a summary of anticipated or unanticipated device-related SAEs.

  3. Evaluate long-term three and five-year therapy-related Serious Adverse Events (SAEs) [ Time Frame: Through 3 and 5 years ]
    Assessment of the safety of the remedē System by evaluating anticipated or unanticipated therapy-related SAEs.

  4. Evaluate long-term effectiveness of the remedē System [ Time Frame: 3 and 5 years ]
    Evaluate the apnea hypopnea index (events/hour) (AHI) using in-home polygram (PG) and at five years using in-lab polysomnogram (PSG)

  5. Evaluate the change in quality of life from baseline to three and five years [ Time Frame: Baseline, 3 and 5 years ]
    Quality of life will be evaluated using the Epworth Sleepiness Scale (ESS) at 3 and 5 years post implant of the remedē System compared to baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible for this trial.
Criteria

Inclusion Criteria:

  • Subjects who were previously implanted with the remedē System and participated in the remedē System Pivotal Trial
  • In the investigator's opinion, willing and able to comply with all study requirements
  • Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent (including Health Insurance Portability and Accountability Act [HIPAA] authorization in the US)

Exclusion Criteria:

  • There are no criteria by which a subject would be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425188


Locations
Layout table for location information
United States, California
Keck Medical Center of USC
Los Angeles, California, United States, 90033
United States, Florida
UF Health Jacksonville
Jacksonville, Florida, United States, 32209
United States, Illinois
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States, 60515
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
United States, Michigan
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68526
United States, New Jersey
Cooper Health System
Cherry Hill, New Jersey, United States, 08034
United States, North Carolina
Novant Clinical Research Institute Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States, 45219
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Wesley Neurology
Cordova, Tennessee, United States, 38018
United States, Texas
Methodist Hospital
San Antonio, Texas, United States, 78229
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Germany
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
Sponsors and Collaborators
Respicardia, Inc.
Investigators
Layout table for investigator information
Study Director: Robin Germany, MD Respicardia, Inc.

Layout table for additonal information
Responsible Party: Respicardia, Inc.
ClinicalTrials.gov Identifier: NCT03425188     History of Changes
Other Study ID Numbers: CR1079
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea, Central
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases