Heart Failure
Conditions
Keywords
Heart Failure, NYHA Class III, NYHA Class IV
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Nuwellis, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is 18 years or older * Patients with moderate to severe ambulatory heart failure \[American College of Cardiology/American Heart Association (ACC/AHA) Stage C; NYHA Class III/IV ambulatory\], who are refractory to optimal medical therapy * Patients who are non-responders to CRT pacemaker therapy * Patient has signed and dated the investigation informed consent form
Exclusion criteria
* Evidence of significant ascending aortic calcification on postero-anterior chest X-ray or CT scan * Moderate or severe atherosclerotic aortic disease * Ascending aorto-coronary artery bypass grafts * Any history of aortic dissection * Connective tissue disorder such as Marfans disease * Aorta not conforming to specified dimensional constraints * Patient has severe mitral valve incompetence, grade 4+ * Patient has moderate to severe aortic valve incompetence, grade 2 - 4+ * Patient has systolic blood pressure less than 90 or greater than 140mmHg * Presence of active systemic infection * Presence of bleeding or coagulation disorder (relative)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival and Study Completion | 5 years | Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death. |
| NYHA Classification | 6 Months | 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 |
| INTERMACS Subject Profile/Status | 6 months | 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 |
| Six Minute Walk Test | 6 months | 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. |
| KCCQ | 6 months | 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. |
Countries
Austria, Germany
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| C-Pulse System A total of 15 subjects were treated with the C-Pulse System. | 15 |
| C-Pulse System A total of 15 subjects were treated with the C-Pulse System. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | C-Pulse System |
|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 9.3 |
| Age, Customized Median | 61 years |
| INTERMACS Subject Profile/Status Advanced NYHA Class III | 1 Participants |
| INTERMACS Subject Profile/Status Exertion Intolerant | 5 Participants |
| INTERMACS Subject Profile/Status Exertion Limited | 4 Participants |
| INTERMACS Subject Profile/Status NA, NYHA class I or II | 2 Participants |
| INTERMACS Subject Profile/Status Resting Symptoms | 3 Participants |
| Kansas City Cardiomyopathy Questionnaire | 30 points STANDARD_DEVIATION 18.5 |
| NYHA Classification I | 0 Participants |
| NYHA Classification II | 0 Participants |
| NYHA Classification III | 14 Participants |
| NYHA Classification IV | 1 Participants |
| Race/Ethnicity, Customized Race European Caucasian | 14 Participants |
| Race/Ethnicity, Customized Race Subject Choose not to Provide | 1 Participants |
| Region of Enrollment Austria | 1 Participants |
| Region of Enrollment Germany | 13 Participants |
| Region of Enrollment United Kingdom | 1 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 12 Participants |
| Six Minute Walk Test | 237.4 meters STANDARD_DEVIATION 85.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 15 |
| other Total, other adverse events | 2 / 15 |
| serious Total, serious adverse events | 14 / 15 |
Outcome results
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
Time frame: 6 months
Population: Only 12 participants remained in the study at the 6-Month follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| C-Pulse System | INTERMACS Subject Profile/Status | Resting Symptoms | 1 Participants |
| C-Pulse System | INTERMACS Subject Profile/Status | Exertion Limited | 1 Participants |
| C-Pulse System | INTERMACS Subject Profile/Status | Advanced NYHA Class III | 2 Participants |
| C-Pulse System | INTERMACS Subject Profile/Status | NA, NYHA class I or II | 8 Participants |
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.
Time frame: 6 months
Population: Only 12 participants were involved in the study at the time of KCCQ.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-Pulse System | KCCQ | 60.3 score on a scale | Standard Deviation 21.1 |
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
Time frame: 6 Months
Population: Only 12 participants remained in the study at the 6-month follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| C-Pulse System | NYHA Classification | NYHA Class I | 2 Participants |
| C-Pulse System | NYHA Classification | NYHA Class II | 6 Participants |
| C-Pulse System | NYHA Classification | NYHA Class III | 4 Participants |
| C-Pulse System | NYHA Classification | NYHA Class IV | 0 Participants |
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.
Time frame: 6 months
Population: Only 9 participants were able to be assessed via 6MWT at the 6-Month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-Pulse System | Six Minute Walk Test | 333.9 Meters | Standard Deviation 112.2 |
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.
Time frame: 5 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| C-Pulse System | Survival and Study Completion | Study completion | 4 Participants |
| C-Pulse System | Survival and Study Completion | Exited Study | 11 Participants |