Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Commercial distribution of the remedē System stopped by LivaNova.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Respicardia, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this post market study is to assess the impact of sleep-disordered breathing on the well-being of patients according to the treatment chosen, i.e. with or without implantation of the remedē® system to treat sleep-disordered breathing.
The sponsor of this study, LivaNova, has a partnership with Respicardia, Inc who has developed a battery-powered implantable device that treats central sleep apnea. The device is used with a lead that delivers the stimulation therapy which causes the patient to breathe with a regular rhythm and an optional lead that senses breathing. This combination is called the remedē® system.
The aim of this study is
The information obtained from this study may provide better insight on the symptoms related to central sleep apnea, risk factors related to central sleep apnea therapy and use of the remedē® system which may help to treat other patients with potential sleep disordered breathing more appropriately.
Approximately 300 patients (to be) implanted with the remedē® system will participate in this study at approximately 40 sites in Europe. For this purpose the investigators aim to screen approximately 1500 patients with sleep-disordered breathing. Also patients diagnosed with central sleep apnea, but not receiving the device will be followed through phone calls for 2 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSA patients without remedē system | For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment. | ||
| CSA patients with remedē system | For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected. Patients will be asked to complete quality of life questionnaires at baseline and during follow-up visits. Patients will be evaluated at the time of therapy activation which may be followed by one or more titration visits. Patient follow-ups will be programmed at 6 and 12 months, and yearly, up to 5 years post-implant, until the last patients reach their 2-year follow-up. Echocardiogram for patients with reduced ejection fraction (≤ 45%) and follow-up respiratory polygraphy are considered standard of care, however, to ensure sufficient data, related to the study objectives, are being collected, baseline and 12-months echocardiogram for a subgroup of patients and respiratory polygraphy at 12-month follow-up for all patients must be done when participating in this study: |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. | Collect short and long term clinical data on safety of the remede system implanted in daily practice. This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient. | From implant up to 5 years (collected until 24 month FU) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline | Evaluate changes in sleep study results at 12 months compared to baseline | 12 months post-implant |
| Impact on Quality of Life Compared to Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea | Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed. | screening |
Inclusion Criteria:
Implant Inclusion criteria
Implant Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with central sleep apnea
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christoph Stellbrink | Bielefeld-Klinikum | Principal Investigator |
| Stefan Anker | Herzzentrum Göttingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Diabeteszentrum Bad Oeynhausen | Bad Oeynhausen | Germany | ||||
| Klinikum Bielefeld Mitte |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CSA Patients NOT Implanted With remedē System | For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment. |
| FG001 | CSA Patients With remedē System | For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected. Patients will be asked to complete quality of life questionnaires at baseline and during follow-up visits. Patients will be evaluated at the time of therapy activation which may be followed by one or more titration visits. Patient follow-ups will be programmed at 6 and 12 months, and yearly, up to 5 years post-implant, until the last patients reach their 2-year follow-up. Echocardiogram for patients with reduced ejection fraction (≤ 45%) and follow-up respiratory polygraphy are considered standard of care, however, to ensure sufficient data, related to the study objectives, are being collected, baseline and 12-months echocardiogram for a subgroup of patients and respiratory polygraphy at 12-month follow-up for all patients must be done when participating in this study: |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CSA Patients NOT Implanted With remedē® System | For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment. |
| 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 | Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. | Collect short and long term clinical data on safety of the remede system implanted in daily practice. This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient. | Viewing the limited amount of data at early study termination, the data should be interpreted with caution. | Posted | Count of Participants | Participants | From implant up to 5 years (collected until 24 month FU) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CSA Patients NOT Implanted With remedē® System | For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Reneal Failure | Renal and urinary disorders | Systematic Assessment | One subject suffered from postoperative acute renal failure due to contrast fluid exposition at implant procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diaphragm stimulation discomfort | General disorders |
Due to the early study termination, the amount of collected data was inconclusive at the time of early study termination to draw any conclusion on the study objectives.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Livanova | 0032498644704 | renske.dezwaef@livanova.com |
Not provided
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients
| Up to 5 years post-implant |
| Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline | Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline | 12 months post implant |
| Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea | Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system | Up to 2 years (collected until 6M FU) |
| Bielefeld |
| Germany |
| Alice Hospital | Darmstadt | Germany |
| Albertinen Krankenhaus | Hamburg | Germany |
| Universitaetsklinikum Schleswig Holstein | Kiel | Germany |
| Klinikum Lünen - St Marien Hospital | Lünen | Germany |
| St. Vincenz-Krankenhaus | Paderborn | Germany |
| Hospital Infanta Cristina | Badajoz | Spain |
| Hospital Universitario de Burgos | Burgos | Spain |
| Hospital de Monteprincipe | Madrid | Spain |
| BG001 |
| CSA Patients With remedē System |
For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline | Evaluate changes in sleep study results at 12 months compared to baseline | A complete dataset is only available for 1 patient and due to confidentiality reasons for this 1 patient we prefer not to present this data. | Posted | 12 months post-implant |
|
|
| Secondary | Impact on Quality of Life Compared to Baseline | Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients | No data available on Quality of Life questionnaires; no patient completed the questionnaires at baseline AND at the 12M/24M follow-up at the time of premature study stop. | Posted | Up to 5 years post-implant |
|
|
| Secondary | Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline | Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline | No data available; no patient had completed a 12 months echo prior to the premature study stop | Posted | 12 months post implant |
|
|
| Secondary | Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea | Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system | No conclusion can be drawn on all-cause mortality and all-cause hospitalization rates for this group of patients;only 3 subjects diagnosed with CSA (not implanted) reached the 6M FU at the time of study termination. No deaths and/or hospitalizations had been reported in this subject group at the time of study termination.No 12M data is available. | Posted | Count of Participants | Participants | Up to 2 years (collected until 6M FU) |
|
|
|
| Other Pre-specified | Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea | Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed. | Posted | screening |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | CSA Patients With remedē System | For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected. | 6 | 17 | 4 | 17 |
|
| Cardiac Decompensation | Cardiac disorders | Systematic Assessment |
|
| Cardiac/cardiorespiratory arrest | Cardiac disorders |
|
| Other cardiac disorders | Cardiac disorders |
|
| Lead Dislocation | Product Issues | lead dislocations led to a system modification which was successful in all three patients, with one patient needing two modifications to achieve stable lead position |
|
| Cardiac decompensation | Cardiac disorders |
|
| beginning liver insufficiency | Gastrointestinal disorders |
|
| Lead Dislocation | Product Issues | 1 lead dislocation was not reported as SAE by site |
|
| atrial arrhythmia | Cardiac disorders |
|
The legal manufacturer of the medical device, Respicardia, shall be the owner of the Clinical study data including any results, and Respicardia shall have the right to control the publication timing, content and method for any public disclosure of the clinical study data. Respicardia's prior written approval must be obtained prior to any publication or disclosure of Clinical study data or results by Sponsor or Institution.
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |