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The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias.
The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study.
It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All enrolled subjects will undergo attempted system implantation and therapeutic assessment. Subjects' baseline assessment values will serve as control parameters for the therapy evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remedē (TM) system | Device | Implantation of the remedē (TM) system, including implantable pulse generator, stimulation lead, and (optional) sensing lead. Nightly provision of unilateral transvenous phrenic nerve therapy during sleep periods. |
| Measure | Description | Time Frame |
|---|---|---|
| AHI Change From Baseline at 3 Months | Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. | Baseline and 3 months on therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Related Adverse Events | The number of subjects with a serious adverse event (SAE) considered related to the remedē system or implant procedure is provided. The number of subjects with a non-SAE related to the remedē system or implant procedure is also provided. Events are included if they occurred on or after the initial implant date through 2 years post implant. A subject may have both SAE and non-SAE events, so the participants with serious events cannot be added to the non-serious participants to get the total number of participants experiencing a related event. |
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Inclusion Criteria:
Candidate is at least 18 years old
Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Ponikowski, MD | 4th Military Clinical Hospital with Polyclinic, Poland | Principal Investigator |
| William T Abraham, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BryanLGH Heart Institute | Lincoln | Nebraska | 68506 | United States | ||
| The Ohio State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30325462 | Derived | Javaheri S, McKane SW, Cameron N, Germany RE, Malhotra A. In patients with heart failure the burden of central sleep apnea increases in the late sleep hours. Sleep. 2019 Jan 1;42(1):zsy195. doi: 10.1093/sleep/zsy195. | |
| 25770408 | Derived | Abraham WT, Jagielski D, Oldenburg O, Augostini R, Krueger S, Kolodziej A, Gutleben KJ, Khayat R, Merliss A, Harsch MR, Holcomb RG, Javaheri S, Ponikowski P; remede Pilot Study Investigators. Phrenic nerve stimulation for the treatment of central sleep apnea. JACC Heart Fail. 2015 May;3(5):360-369. doi: 10.1016/j.jchf.2014.12.013. Epub 2015 Mar 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects with an implant attempt.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep. |
| 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 | AHI Change From Baseline at 3 Months | Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. | The evaluable population includes subjects who completed a 3 Month post therapy initiation visit. | Posted | Mean | Standard Deviation | events/hour | Baseline and 3 months on therapy |
|
|
2 years
Events are included if they occurred on or after the initial implant date through 2 years post implant.
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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 | Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE CONGESTIVE HEART FAILURE | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIAPHRAGMATIC STIMULATION DISCOMFORT | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Nelson, VP Clinical Affairs | Respicardia | 952-540-4479 | lnelson@respicardia.com |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D002639 | Cheyne-Stokes Respiration |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Up to 2 years |
| Epworth Sleepiness Scale Change From Baseline at 6 Months | Change = Month 6 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. | Baseline and 6 months on therapy |
| Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months | Change = Month 6 score - Baseline score This questionnaire was for the N=46 patients diagnosed with heart failure. Scores can range from 0-105, with lower scores indicating better quality of life. | Baseline and 6 months on therapy |
| Heart Failure Clinical Composite | The composite is determined according to the following definitions. Worsened: subject died; was hospitalized due to or associated with worsening HF; demonstrated worsening in NYHA class at last observation carried forward; moderate-marked worsening of patient global assessment score at last observation carried forward; or permanently discontinued therapy from the remedē System due to or associated with worsening HF. Improved: subject did not worsen (as defined above) and demonstrated improvement in NYHA class at last observation carried forward or moderate-marked improvement in patient global assessment score at last observation carried forward. Unchanged: patient was neither improved nor worsened. | 6 months on therapy |
| Six-minute Hall Walk Test Change From Baseline at 6 Months | Change = Month 6 score - Baseline score | Baseline and 6 months on therapy |
| NYHA Functional Class Improvement From Baseline to 6 Months | Shift in NYHA Class from baseline to 6 months NYHA Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain. NYHA Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. NYHA Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. NYHA Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present event at rest. If any physical activity is undertaken, discomfort increases. | Baseline and 6 months on therapy |
| Columbus |
| Ohio |
| United States |
| Lancaster Heart and Stroke Foundation | Lancaster | Pennsylvania | 17602 | United States |
| St. Thomas Heart | Nashville | Tennessee | United States |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | United States |
| Heart and Diabetes Center | Bad Oeynhausen | Germany |
| Köln University | Cologne | Germany |
| University of Kiel | Kiel | Germany |
| St. Adolf-Stift Hospital | Reinbek | Germany |
| Policlinico di Monza-IRCCS | Monza | Italy |
| Jagiellonian University | Krakow | Poland |
| Medical Military Institute | Warsaw | Poland |
| 4th Military Hospital | Wroclaw | Poland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Apnea-Hypopnea Index (AHI) | 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 | Mean | Standard Deviation | events/hour |
|
| Epworth Sleepiness Scale (ESS) | 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. | Mean | Standard Deviation | units on a scale |
|
| Minnesota Living with Heart Failure Questionnaire (MNLHF) | This questionnaire was for the N=46 patients diagnosed with heart failure. Scores can range from 0-105, with lower scores indicating better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Six minute hall walk | N=55 subjects completed this assessment at baseline. | Mean | Standard Deviation | meters |
|
| New York Heart Association (NYHA) Functional Class | NYHA Class definitions: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea Class II:Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of HF at rest. If any physical activity is undertaken, discomfort increases. | Number | participants |
|
| Heart failure | Number | participants |
|
| Ejection Fraction | Available for N=54 participants. | Mean | Standard Deviation | percent |
|
| Coronary Artery Disease | Number | participants |
|
| Hypertension | Number | participants |
|
| Hyperlipidemia | Number | participants |
|
| Atrial Fibrillation | Number | participants |
|
| Concomitant implantable device delivering therapy | Number | participants |
|
| Participants |
|
|
|
| Secondary | Related Adverse Events | The number of subjects with a serious adverse event (SAE) considered related to the remedē system or implant procedure is provided. The number of subjects with a non-SAE related to the remedē system or implant procedure is also provided. Events are included if they occurred on or after the initial implant date through 2 years post implant. A subject may have both SAE and non-SAE events, so the participants with serious events cannot be added to the non-serious participants to get the total number of participants experiencing a related event. | Subjects with an implant attempt. | Posted | Number | participants | Up to 2 years |
|
|
|
| Secondary | Epworth Sleepiness Scale Change From Baseline at 6 Months | Change = Month 6 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. | Subjects with baseline and 6 month data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months on therapy |
|
|
|
| Secondary | Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months | Change = Month 6 score - Baseline score This questionnaire was for the N=46 patients diagnosed with heart failure. Scores can range from 0-105, with lower scores indicating better quality of life. | Heart failure subjects with baseline and 6 month results. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months on therapy |
|
|
|
| Secondary | Heart Failure Clinical Composite | The composite is determined according to the following definitions. Worsened: subject died; was hospitalized due to or associated with worsening HF; demonstrated worsening in NYHA class at last observation carried forward; moderate-marked worsening of patient global assessment score at last observation carried forward; or permanently discontinued therapy from the remedē System due to or associated with worsening HF. Improved: subject did not worsen (as defined above) and demonstrated improvement in NYHA class at last observation carried forward or moderate-marked improvement in patient global assessment score at last observation carried forward. Unchanged: patient was neither improved nor worsened. | Evaluable subjects with heart failure at baseline. | Posted | Number | participants | 6 months on therapy |
|
|
|
| Secondary | Six-minute Hall Walk Test Change From Baseline at 6 Months | Change = Month 6 score - Baseline score | Subjects with baseline and 6 month data. | Posted | Mean | Standard Deviation | meters | Baseline and 6 months on therapy |
|
|
|
| Secondary | NYHA Functional Class Improvement From Baseline to 6 Months | Shift in NYHA Class from baseline to 6 months NYHA Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain. NYHA Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. NYHA Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. NYHA Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present event at rest. If any physical activity is undertaken, discomfort increases. | Heart failure subjects with 6 month data. | Posted | Number | participants | Baseline and 6 months on therapy |
|
|
|
| 41 |
| 57 |
| 35 |
| 57 |
| LEAD DISLODGEMENT | General disorders | Non-systematic Assessment |
|
| VENTRICULAR ARRHYTHMIA | Cardiac disorders | Non-systematic Assessment |
|
| ACUTE CORONARY SYNDROME | Cardiac disorders | Non-systematic Assessment |
|
| ATRIAL ARRHYTHMIA | Cardiac disorders | Non-systematic Assessment |
|
| CHEST PAIN | Cardiac disorders | Non-systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | Non-systematic Assessment |
|
| CLOSTRIDIAL ENTERITIS | Gastrointestinal disorders | Non-systematic Assessment |
|
| EXTRA-RESPIRATORY STIMULATION | General disorders | Non-systematic Assessment |
|
| LEAD COMPONENT FAILURE | General disorders | Non-systematic Assessment |
|
| BRONCHITIS | Infections and infestations | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | Non-systematic Assessment |
|
| HYPOGLYCEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| FRACTURE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| STROKE | Nervous system disorders | Non-systematic Assessment |
|
| URINARY TRACT INFECTION | Renal and urinary disorders | Non-systematic Assessment |
|
| THROMBOSIS | Vascular disorders | Non-systematic Assessment |
|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | Non-systematic Assessment |
|
| AV BLOCK | Cardiac disorders | Non-systematic Assessment |
|
| HYPERTHYROIDISM | Endocrine disorders | Non-systematic Assessment |
|
| DETACHED RETINA | Eye disorders | Non-systematic Assessment |
|
| WORSENING OF CATARACTS | Eye disorders | Non-systematic Assessment |
|
| GASTROENTERITIS | Gastrointestinal disorders | Non-systematic Assessment |
|
| GI BLEEDING | Gastrointestinal disorders | Non-systematic Assessment |
|
| HERNIA REPAIR | General disorders | Non-systematic Assessment |
|
| IMPENDING POCKET PERFORATION | General disorders | Non-systematic Assessment |
|
| INADEQUATE LEAD POSITION | General disorders | Non-systematic Assessment |
|
| LOSS OF STIMULATION | General disorders | Non-systematic Assessment |
|
| ATYPICAL PNEUMONIA | Infections and infestations | Non-systematic Assessment |
|
| DIABETES | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPEROSMOLAR SYNDROME | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| ATYPICAL CHEST PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| GOUT ATTACK | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SPINAL CANAL STENOSIS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| HEAD AND NECK CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| EPILEPTIC SEIZURE | Nervous system disorders | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | Non-systematic Assessment |
|
| MENINGIOMA | Nervous system disorders | Non-systematic Assessment |
|
| DELUSIONAL SYNDROME | Psychiatric disorders | Non-systematic Assessment |
|
| RENAL DYSFUNCTION | Renal and urinary disorders | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | Non-systematic Assessment |
|
| COPD EXACERBATION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| PULMONITIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| VOCAL CORD LESION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| ATOPIC ECZEMA | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| CRT-D DEVICE REPLACEMENT | Surgical and medical procedures | Non-systematic Assessment |
|
| DEVICE EXPLANTATION | Surgical and medical procedures | Non-systematic Assessment |
|
| HEMATOMA | Vascular disorders | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | Non-systematic Assessment |
|
| PERIPHERAL VASCULAR DISEASE | Vascular disorders | Non-systematic Assessment |
|
| URINARY TRACT INFECTION | Renal and urinary disorders | Non-systematic Assessment |
|
| ACUTE CONGESTIVE HEART FAILURE | Cardiac disorders | Non-systematic Assessment |
|
| EXTRA-RESPIRATORY STIMULATION | General disorders | Non-systematic Assessment |
|
| PAIN | General disorders | Non-systematic Assessment |
|
| HEMATOMA | Vascular disorders | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | Non-systematic Assessment |
|
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|