Heart FailureOPTIONS-HFNCT01872949
C-Pulse® System European Multicenter Study
An observational study of Heart Failure, run by Nuwellis, Inc. at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 15 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 13 Jan 2014to 21 Jun 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany7 sites
Cardio-Centrum Berlin
Berlin, 10117
Vivantes Klinikum
Berlin, 10249
Unfallkrankenhaus
Berlin
Evangelisches Krankenhaus Niederrhein
Duisburg, Northrhine-Westfalia, 47169
Universitätsklinikum Erlangen
Erlangen, 91054
Medizinische Hochschule
Hanover
Universität Tübingen
Tübingen, 72076
About this study
Official title: C-Pulse System eurOPean mulTicenter Study, Implantable cOuNterpulsation System in patIents With Moderate to Severe Heart Failure
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.
Read the 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.
- Conditions
- Heart Failure
- Keywords
- Heart Failure, NYHA Class III, NYHA Class IV
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 Months
INTERMACS Subject Profile/Status
- 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
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study start13 Jan 2014
- Primary completion7 May 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuwellis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872949
- Sponsor's protocol ID
- PRO 04654-C
- Acronym
- OPTIONS-HF
- Status last verified
- Aug 2023
- First submitted
- 4 Jun 2013
- Last updated
- 8 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26887528
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-Pulse System eurOPean mulTicenter Study, Implantable cOuNterpulsation System in patIents With Moderate to Severe Heart Failure
- ClinicalTrials.gov ID
- NCT01872949
- Acronym / sponsor ID
- OPTIONS-HF / PRO 04654-C
- Conditions
- Heart Failure
- Keywords
- Heart Failure, NYHA Class III, NYHA Class IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nuwellis, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2014 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Posted 8 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival and Study Completion
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26887528Schulz 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Nuwellis, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival and Study Completion (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023; AzTrials last refreshed its copy on 27 Oct 2026.