Clinical trial NCT03425188: Post Approval Study of the remedē System
Official title: Post Approval Study of the remedē System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Sleep Apnea
Lead sponsor: Respicardia, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 53
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: 5-Year Survival Rate
timeFrame: Through 5 years
measure: Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years
timeFrame: Through 5 years
measure: Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years
timeFrame: Through 3 and 5 years
measure: Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years
timeFrame: 5 years
measure: Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Downers Grove
country: United States
facility: Advocate Good Samaritan Hospital
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Cherry Hill
country: United States
facility: Cooper Health System
state: New Jersey
city: Winston-Salem
country: United States
facility: Novant Clinical Research Institute Forsyth Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center for Research & Education at The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Cordova
country: United States
facility: Wesley Neurology
state: Tennessee
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum NRW
Study officials:
affiliation: Respicardia, Inc.
name: Robin Germany, MD
role: STUDY_DIRECTOR
References: