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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible for this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Robin Germany, MD | Respicardia, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medical Center of USC | Los Angeles | California | 90033 | United States | ||
| UF Health Jacksonville |
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151 subjects enrolled in the original pivotal trial of the remede system. 94 were ongoing at the time of trial closure and therefore eligible to participate in this continuation post approval study. Pivotal trial sites with subjects ongoing at the time of study closure were invited to participate in this long-term continuation study. Subjects needed to re-consent to participate. Due to sites or subjects declining participation, not all subjects participated in this continuation study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study. This is a subset of the 151 subjects enrolled in the original pivotal trial of the remede System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Through 5 years |
|
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.
In addition to the usual serious adverse event definitions, this study included any device or therapy related adverse event that required a system modification (excluding generator replacement for battery depletion within anticipated timeframe or elective explant), regardless of the procedure being to prevent one of the outcomes listed in the usual serious adverse event definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Subjects implanted with the remedē System device, receiving active therapy and enrolled in the post approval study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEART FAILURE | Cardiac disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Meyer, VP Clinical Affairs | Respicardia, Inc. | 952-540-4479 | tmeyer@respicardia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 9, 2018 | Feb 3, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 5 years |
| Jacksonville |
| Florida |
| 32209 |
| United States |
| Advocate Good Samaritan Hospital | Downers Grove | Illinois | 60515 | United States |
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
| United Heart and Vascular Clinic | Saint Paul | Minnesota | 55102 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Nebraska Heart Institute | Lincoln | Nebraska | 68526 | United States |
| Cooper Health System | Cherry Hill | New Jersey | 08034 | United States |
| Novant Clinical Research Institute Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| The Lindner Center for Research & Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Wesley Neurology | Cordova | Tennessee | 38018 | United States |
| Methodist Hospital | San Antonio | Texas | 78229 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Herz-und Diabeteszentrum NRW | Bad Oeynhausen | 32545 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Heart failure | Defined as New York Heart Association (NYHA) Functional Class ≥ I | Count of Participants | Participants |
|
| Apnea Hypopnea Index | The number of apneas and hypopneas per hour of sleep. An apnea is defined by 3 characteristics:
Hypopnea defined as 30% reduction in airflow (or alternative hypopnea sensor) for ≥10 seconds over at least 90% of the event's duration that is associated with a >4% fall in oxygen saturation from baseline. | Median | Inter-Quartile Range | events/hour |
|
| Epworth Sleepiness Scale | The Epworth Sleepiness Scale 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. | Median | Inter-Quartile Range | units on a scale |
|
|
|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Through 5 years |
|
|
|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Through 3 and 5 years |
|
|
|
| Primary | 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). | 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. | Posted | Median | Inter-Quartile Range | Events/hour | 5 years |
|
|
|
| Primary | 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. | Includes all subjects who completed the ESS at 5 years. This is a subgroup of subjects from the original pivotal trial who enrolled in this post approval study and had data available at 5 years. | Posted | Median | Inter-Quartile Range | units on a scale | 5 years |
|
|
|
| 0 |
| 53 |
| 23 |
| 53 |
| 3 |
| 53 |
| ACUTE CORONARY SYNDROME | Cardiac disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY | Cardiac disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| SINUS BRADYCARDIA | Cardiac disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| VENTRICULAR TACHYCARDIA | Cardiac disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| HYPOTHYROIDISM | Endocrine disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| INGUINAL HERNIA | Gastrointestinal disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| IMPLANT SITE INFECTION | General disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| INGROWN TOENAIL | General disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| LEAD COMPONENT FAILURE | General disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| LEAD DISLODGEMENT | General disorders | Modified CTCAE v4.03 | Non-systematic Assessment | The stimulation lead pulled out of the target vessel and required the lead to be replaced in order to deliver therapy |
|
| LEAD DISPLACEMENT | General disorders | Modified CTCAE v4.03 | Non-systematic Assessment | The stimulation lead remained in the target vessel but electrode position did not allow for effective therapy delivery |
|
| SIMULATION LEAD EXTRACTION | General disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| STIMULATION LEAD PLACEMENT | General disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| ABSCESS | Infections and infestations | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| APPENDICITIS | Infections and infestations | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| SEPSIS | Infections and infestations | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| ROTATOR CUFF TEAR | Injury, poisoning and procedural complications | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| PROSTATE CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| STROKE | Nervous system disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| PARESTHESIA | Nervous system disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| SYNCOPE | Nervous system disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| TRANSIENT ISCHEMIC ATTACKS | Nervous system disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| URINARY TRACT PAIN | Renal and urinary disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| PAIN PUMP IMPLANT | Surgical and medical procedures | Modified CTCAE v4.03 | Non-systematic Assessment |
|
| HYPERTENSION | Vascular disorders | Modified CTCAE v4.03 | Non-systematic Assessment |
|
Without prior written agreement of the Sponsor, Research Institution and site Principal Investigator agree not to publish results for at least 1 year from finalization of the study database, after which time site Principal Investigator may publish or submit for publication a Manuscript without further delay subject to the sponsor having 60 days to review the proposed publication and additional 90 day provision if intellectual property is at risk to allow time for submitting patent applications.
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |