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The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System in the usual manner and according to the approved indications and contraindications.
Evaluation of the post-market clinical performance and safety of the C-Pulse® System for the treatment of Heart Failure in the population of patients who meet the approved clinical conditions provided in the indications and contraindications.
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| Measure | Description | Time Frame |
|---|---|---|
| Survival and Study Completion | Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death. | 5 years |
| NYHA Classification | Participant NYHA Classification at 6 month follow up. The NYHA Classification involved 4 classes. I No limitation of physical activity II Slight limitation of physical activity III Marked limitation of physical activity IV Unable to carry on any physical activity without discomfort | 6 Months |
| INTERMACS Subject Profile/Status | 1. Critical Cardiogenic Shock, 2. Progressive Decline, 3. Stable but Inotrope Dependent, 4. Resting Symptoms, 5. Exertion Intolerant, 6. Exertion Limited, 7. Advanced NYHA Class III, 8. NA/NYHA class I or II | 6 months |
| Six Minute Walk Test | The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. | 6 months |
| KCCQ | Overall score from Kansas City Cardiomyopathy Questionnaire, a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status,which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. Scores range from 0-100, in which higher scores reflect better health status. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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A patient population of up to 50 patients with moderate to severe heart failure refractory to optimal medical therapy, who are implanted with the C-Pulse System as clinically appropriate, will be enrolled into the Study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Innsbruck | 6020 | Austria | |||
| Evangelisches Krankenhaus Niederrhein |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26887528 | Derived | Schulz A, Krabatsch T, Schmitto JD, Hetzer R, Seidel M, Dohmen PM, Hotz H. Preliminary Results From the C-Pulse OPTIONS HF European Multicenter Post-Market Study. Med Sci Monit Basic Res. 2016 Feb 18;22:14-9. doi: 10.12659/MSMBR.896959. |
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The OPTIONS-HF is a prospective, post-market, open label study designed to enroll up to 50 patients in up to fifteen (15) European sites. Only 15 subjects were implanted.
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| ID | Title | Description |
|---|---|---|
| FG000 | C-Pulse System | Single-arm study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | C-Pulse System | A total of 15 subjects were treated with the C-Pulse System. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Survival and Study Completion | Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death. | Posted | Count of Participants | Participants | 5 years |
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5 years
Events for the C-Pulse European study were reported by Investigators using the INTERMACS ™ Adverse Event Definitions as a guideline.
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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 | C-Pulse System | A total of 15 subjects were treated with the C-Pulse System. The study follow-up period was up to 5 years. However, the data collection for subjects was up to 24-months. Only 3 subjects completed the 24 months follow-up visit, and 12 subjects prematurely exited the study prior to the 24 months follow-up. \Rate subjects with averse event 93% (14/15). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Infection | Infections and infestations | INTERMACS | Non-systematic Assessment | A clinical infection accompanied by pain, fever, drainage and/or leukocytosis that is treated by anti-microbial agents (non-prophylactic). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | INTERMACS | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Audrey Singh | CHF Solutions, Inc. | 952-345-4217 | audrey.singh@chf-solutions.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2014 | Jul 10, 2019 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Duisburg |
| Northrhine-Westfalia |
| 47169 |
| Germany |
| Cardio-Centrum Berlin | Berlin | 10117 | Germany |
| Vivantes Klinikum | Berlin | 10249 | Germany |
| Unfallkrankenhaus | Berlin | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Medizinische Hochschule | Hanover | Germany |
| Universität Tübingen | Tübingen | 72076 | Germany |
| implants |
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| years |
| Participants |
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| Age, Customized | Median | Full Range | years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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| NYHA Classification | NYHA Classification provides a simple way of classifying the extent of heart failure. Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | Count of Participants | Participants | Participants |
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| INTERMACS Subject Profile/Status | 1. Critical Cardiogenic Shock, 2. Progressive Decline, 3. Stable but Inotrope Dependent, 4. Resting Symptoms, 5. Exertion Intolerant, 6. Exertion Limited, 7. Advanced NYHA Class III, or 8. NA/NYHA class I or II | Count of Participants | Participants | Participants |
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| Six Minute Walk Test | The six minute walk test (6MWT) is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired patients. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). | Mean | Standard Deviation | meters | Participants |
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| Kansas City Cardiomyopathy Questionnaire | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | Number analyzed is different from overall participants because one participant did not take the KCCQ. | Mean | Standard Deviation | points | Participants |
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| Primary | NYHA Classification | Participant NYHA Classification at 6 month follow up. The NYHA Classification involved 4 classes. I No limitation of physical activity II Slight limitation of physical activity III Marked limitation of physical activity IV Unable to carry on any physical activity without discomfort | Only 12 participants remained in the study at the 6-month follow-up. | Posted | Count of Participants | Participants | 6 Months |
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| Primary | INTERMACS Subject Profile/Status | 1. Critical Cardiogenic Shock, 2. Progressive Decline, 3. Stable but Inotrope Dependent, 4. Resting Symptoms, 5. Exertion Intolerant, 6. Exertion Limited, 7. Advanced NYHA Class III, 8. NA/NYHA class I or II | Only 12 participants remained in the study at the 6-Month follow-up. | Posted | Count of Participants | Participants | 6 months |
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|
| Primary | Six Minute Walk Test | The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. | Only 9 participants were able to be assessed via 6MWT at the 6-Month follow-up. | Posted | Mean | Standard Deviation | Meters | 6 months |
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| Primary | KCCQ | Overall score from Kansas City Cardiomyopathy Questionnaire, a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status,which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. Scores range from 0-100, in which higher scores reflect better health status. | Only 12 participants were involved in the study at the time of KCCQ. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| 6 |
| 15 |
| 14 |
| 15 |
| 2 |
| 15 |
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| Cardiac Arrhythmias | Cardiac disorders | INTERMACS | Systematic Assessment | Including sustained ventricular and supraventricular arrhythmias |
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| Worsening Left Heart Failure | Cardiac disorders | INTERMACS | Systematic Assessment |
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| IV |
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| Advanced NYHA Class III |
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| NA, NYHA class I or II |
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| Title | Measurements |
|---|---|
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| NYHA Class IV |
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| NA, NYHA class I or II |
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