Central Sleep ApneaNCT03425188

Post Approval Study of the remedē System

An observational study of Central Sleep Apnea, run by Respicardia, Inc. at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Central Sleep Apnea
How many people: 53 participants
Where: 17 sitesin 2 countries
Study dates: 28 Jun 2018to 4 Aug 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible for this trial.

Who may be able to join

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)

Who cannot join

There are no criteria by which a subject would be excluded

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

United States16 sites

University of Maryland, Baltimore
Baltimore, Maryland, 21201
Cooper Health System
Cherry Hill, New Jersey, 08034
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, 45219
The Ohio State University
Columbus, Ohio, 43210
Wesley Neurology
Cordova, Tennessee, 38018
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
UF Health Jacksonville
Jacksonville, Florida, 32209
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Keck Medical Center of USC
Los Angeles, California, 90033
Marshfield Clinic
Marshfield, Wisconsin, 54449
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102
Methodist Hospital
San Antonio, Texas, 78229
Washington University in St. Louis
St Louis, Missouri, 63110
Novant Clinical Research Institute Forsyth Medical Center
Winston-Salem, North Carolina, 27103

Other trials in United States

Germany1 site

Herz-und Diabeteszentrum NRW
Bad Oeynhausen, 32545

Other trials in Germany

About this study

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

Read the 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.

Conditions: Central Sleep Apnea
Medical subject headings: Sleep Apnea, Central

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03425188
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

5-Year Survival Rate
Assessment of survival in subjects with moderate to severe central sleep apnea being treated with the remedē System. The 5-year survival rate was estimated from Kaplan-Meier anlaysis, using time from implant to death, study exit or last contact. This analysis used all subjects enrolled in the original remede System Pivotal Trial.
Measured: Through 5 years
Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years
Assessment of long-term safety via a summary of anticipated or unanticipated device-related SAEs. Proportion of subjects experiencing a device related SAE through the time point of interest. This analysis combined data from the original pivotal trial and this post approval study.
Measured: Through 5 years
Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years
Assessment of the safety of the remedē System by evaluating anticipated or unanticipated therapy-related SAEs. Proportion of subjects experiencing a therapy related SAE through the time point of interest.
Measured: Through 3 and 5 years
Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years
Change in AHI = Year 5 index - Baseline index. The Apnea-Hypopnea Index is a measurement obtained from an overnight sleep study used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The events were scored according to the 2007 "American Academy of Sleep Medicine manual for the scoring of sleep and associated events: rules, terminology and technical specifications" (Iber, et. al).
Measured: 5 years
Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years
Change in ESS = Year 5 score - Baseline score. The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 20184 Aug 2020

First posted7 Feb 2018
Study start28 Jun 2018
Primary completion4 Aug 2020
Study completion4 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Central Sleep ApneaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03425188
Sponsor's protocol ID: CR1079
Status last verified: Apr 2021
First submitted: 25 Jan 2018
Last updated: 22 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Recruiting
Myofunctional Therapy for Children With OSA
Obstructive Sleep Apnea (OSA)
RecruitingPhase 4
Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment
Sleep Disordered Breathing, Able Bodied
Not yet recruiting
Pediatric/Adolescent WatchPAT 400 Reliability Pilot Study
Pediatric Sleep Disordered Breathing, Obstructive Sleep Apnea

All Central Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Approval Study of the remedē System
ClinicalTrials.gov ID: NCT03425188
Acronym / sponsor ID: CR1079
Conditions: Central Sleep Apnea
Study type: Observational
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Respicardia, Inc.Industry (pharma, biotech, devices)
Study start: 28 Jun 2018 (actual)
Primary completion: 4 Aug 2020 (actual)
Study completion: 4 Aug 2020 (actual)
First posted: 7 Feb 2018 (actual)
Results: Posted 22 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible for this trial.

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (1 listed)

There are no criteria by which a subject would be excluded

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

5-Year 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. The 5-year survival rate was estimated from Kaplan-Meier anlaysis, using time from implant to death, study exit or last contact. This analysis used all subjects enrolled in the original remede System Pivotal Trial.
Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years
Time frame: Through 5 years
Assessment of long-term safety via a summary of anticipated or unanticipated device-related SAEs. Proportion of subjects experiencing a device related SAE through the time point of interest. This analysis combined data from the original pivotal trial and this post approval study.
Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years
Time frame: Through 3 and 5 years
Assessment of the safety of the remedē System by evaluating anticipated or unanticipated therapy-related SAEs. Proportion of subjects experiencing a therapy related SAE through the time point of interest.
Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years
Time frame: 5 years
Change in AHI = Year 5 index - Baseline index. The Apnea-Hypopnea Index is a measurement obtained from an overnight sleep study used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The events were scored according to the 2007 "American Academy of Sleep Medicine manual for the scoring of sleep and associated events: rules, terminology and technical specifications" (Iber, et. al).
Epworth Sleepiness Scale (ESS) Change From Baseline at 5 Years
Time frame: 5 years
Change in ESS = Year 5 score - Baseline score. The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.

Results and safety

Results posted to the registry on 22 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	53	52

Primary outcome: 5-Year Survival Rate

Time frame: Through 5 years. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Enrolled in Pivotal Trial n = 151
Value	78 (71 to 85)

Population analysed: All 151 subjects enrolled in the remedē System Pivotal Trial (NCT01816776) underwent an implant attempt and are included in this analysis. Longer term follow-up data from the subset of pivotal trial subjects enrolled in this post approval study was combined with the data from the pivotal trial for this analysis.

Primary outcome: Number of Participants With Device-related Serious Adverse Events (SAEs) Through Three and Five Years

Time frame: Through 5 years. Count of participants. Unit: Participants

Measure	Enrolled in Pivotal Trial n = 151
3 Years	9
5 Years	12

Primary outcome: Number of Participants With Therapy-related Serious Adverse Events (SAEs) Through Three and Five Years

Time frame: Through 3 and 5 years. Count of participants. Unit: Participants

Measure	Enrolled in Pivotal Trial n = 151
3 Years	4
5 Years	4

Primary outcome: Apnea-Hypopnea Index (AHI) Change From Baseline at 5 Years

Time frame: 5 years. Median (Inter-Quartile Range). Unit: Events/hour

Measure	Treatment n = 43
Value	-22 (-42 to -7)

Population analysed: Includes all subjects who had 5 year sleep study results who were receiving active therapy during the sleep study. This is a subgroup of subjects from the original pivotal trial who enrolled in this post approval study and had sleep study data available at 5 years.

Adverse events

Time frame: The time period includes events experienced by subjects who enrolled in this long term follow-up study, starting from time of completion of the pivotal trial and continuing through 5 years post-implant. All subjects had completed at least 2 years in the pivotal trial prior to study closure and enrollment in this long term follow-up study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	23 of 53 (43.4%)	3 of 53 (5.7%)	0 of 53

Limitations and caveats (from the sponsor): The original pivotal trial of the remede System (ClinicalTrials.gov Identifier: NCT01816776) enrolled 151 subjects and was closed following FDA approval of the PMA submission. This post approval study was initiated as a separate study to continue following as many of the 94 patients ongoing at the time of pivotal trial closure. Due to some sites declining to participate and multiple subjects declining to re-consent, the number of enrolled subjects was less than originally planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Central Sleep Apnea

Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Recruiting
Myofunctional Therapy for Children With OSA
Obstructive Sleep Apnea (OSA)
RecruitingPhase 4
Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment
Sleep Disordered Breathing, Able Bodied
Not yet recruiting
Pediatric/Adolescent WatchPAT 400 Reliability Pilot Study
Pediatric Sleep Disordered Breathing, Obstructive Sleep Apnea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robin Germany, MD study director

Respicardia, Inc.

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Central Sleep Apnea, run by Respicardia, Inc. at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-Year Survival Rate (time frame: Through 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03425188.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.