Heart FailureCOUNTER-HFNCT01740596
C-Pulse® System: A Heart Assist Device Clinical Study
A study testing C-Pulse® System Counterpulsation in people with Heart Failure, run by Nuwellis, Inc. at 28 sites in United States.
Trial summary
Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse® System ("C-Pulse"). The purpose of the study is to determine whether the use of the C-Pulse as a treatment for patients in moderate to severe heart failure (HF) has demonstrated safety and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- C-Pulse® System Counterpulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 28 sitesUnited States
- Study dates
- 12 Sep 2012to 26 Oct 2018
- Phase
- Interventional
- 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
Who may be able to join
- Left ventricular ejection fraction (LVEF) ≤ 35% (by transthoracic ECHO within 90 days prior to randomization)
- ACC/AHA Stage C and NYHA III to ambulatory Class IV
- Age ≥ 18 years
- Must have cardiac resynchronization therapy (CRT) when clinically indicated, implanted ≥90 days prior to randomization.
- Must have an implanted cardio-defibrillator (ICD) when clinically indicated, implanted at least 30 days prior to randomization.
- Note: If a subject is clinically indicated for an ICD but refuses the ICD, he/she may be enrolled. Please document the refusal of the ICD in the medical record and the eCRFs.
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- Patient must be on stable, up-titrated medical therapy as recommended according to current guidelines (Circulation. 2009; 119 (12): 1977-2016) which minimally includes:
- ACE-inhibitor (ACE-I) at stable doses for 1 month prior to enrollment, if tolerated, AND
- a beta blocker (carvedilol, sustained release metoprolol succinate, or bisoprolol) for 3 months prior to enrollment, if tolerated, with a stable up-titrated dose for 1 month prior to enrollment.
- This also includes an Angiotensin II Receptor Blocker (ARB) at stable doses for 1 month prior to enrollment, if tolerated, when ACE-I is not tolerated.
- Stable is defined as no more than a 100% increase or a 50% decrease in dose. If the patient is intolerant to ACE-I, ARB, or beta blockers, documented evidence must be available.
- In those intolerant to both ACE-I and ARB, combination therapy with hydralazine and oral nitrate should be considered. Therapeutic equivalence for ACE-I substitutions is allowed within the enrollment stability timelines.
- Aldosterone inhibitor therapy should be added. Eplerenone requires dosage stability for 1 month prior to enrollment.
- Diuretics may be used as necessary to keep the patient euvolemic.
- Functional limitation due to heart failure as defined by a 6 Minute Walk test of ≥ 175 ≤ 375 meters, measured within 30 days prior to randomization
- At least one hospitalization for decompensated heart failure as defined below, while on heart failure medications, within 12 months prior to randomization or BNP level > 300 or NTproBNP > 1500
- Heart failure related hospitalization is defined by the following:
- signs and symptoms of worsening heart failure; and
- treatment with intravenous heart failure therapy (including but not limited to diuretic or inotropic therapy) and
- a minimum of one date change in the hospital
- Patient understands the nature of the procedure and on-going device therapy, is willing to comply with associated follow-up evaluations, and provide written informed consent prior to the procedure.
Who cannot join
- Any evidence, as assessed within 90 days prior to enrollment, of either:
- Ascending aortic calcification on posterior-anterior or lateral chest x-ray
- Calcific ascending aortic disease as detected by non-contrast CT scan
- Ascending aorto-coronary artery bypass grafts, history of aortic dissection, Marfans disease or other connective tissue disorder or repaired aortic coarctation OR
- Has had an ascending aortic composite graft or root replacement
- Aorta not conforming to specified dimensional constraints defined by CT scan, most specifically mid ascending aortic outside diameter less than 28 mm or greater than 42 mm
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- Inotrope dependence - inability to wean from inotropic therapy
- ACC/AHA Stage D heart failure or non-ambulatory NYHA Class IV subject
- Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, diastolic heart failure or technically challenging congenital heart disease
- Reversible cause of heart failure that may be remedied by conventional surgery or other intervention
- Moderate to severe aortic insufficiency (≥ 2+)
- ST elevation myocardial infarction (STEMI) within 30 days prior to randomization
- Cardiac surgery within 90 days prior to randomization
- Prior cardiac transplantation, left ventricular reduction surgery, passive restraint device or surgically implanted left ventricular assist device
- Anticipated concomitant cardiac surgical procedure
- Serum creatinine ≥ 2.5mg/dL or any form of dialysis within 30 days prior to randomization
- Evidence of intrinsic hepatic disease as defined as biopsy proven liver cirrhosis; or liver enzyme values (AST, ALT or total bilirubin) that are > 3 times the upper limit of normal within 30 days prior to randomization
- Patient has severe intrinsic pulmonary disease in judgment of the investigator
- Body Mass Index (BMI) < 18 or > 45 kg/m2
- Suspected or active systemic infection
- Within 14 days prior to randomization and
- Evidenced by positive culture, antibiotics for empiric treatment or elevated WBC > 12K and temperature >38o C
- Stroke or transient ischemic attack (TIA) within the 90 days prior to randomization; or > 80% carotid stenosis as determined by carotid Doppler ultrasound within 90 days prior to randomization
- Positive serum pregnancy test, for women of childbearing potential
- Patient has a condition, other than heart failure, which would limit survival to less than 2 years
- Patient is currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study
- Patient demonstrates compliance issues that in the opinion of the investigator could interfere with the ability to manage the therapy (i.e. uncontrolled diabetes, mental health issues, etc.)
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
The University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35249
Charlotte-Mecklenburg Hospital - Carolinas Health Care System
Charlotte, North Carolina, 28203
Morton Plant Hospital
Clearwater, Florida, 33756
The Ohio State University Medical Center
Columbus, Ohio, 43210
Dallas VA Medical Center
Dallas, Texas, 75216
Hershey Medical Center
Hershey, Pennsylvania, 17033
Memorial Healthcare System
Hollywood, Florida, 33021
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Texas Heart Institute - St Luke's Hospital
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Mid America Heart Institute-Saint Luke's Hospital
Kansas City, Missouri, 64111
Nebraska Heart Institute
Lincoln, Nebraska, 68526
University of Southern California Keck School of Medicine
Los Angeles, California, 90033
University of Louisville - Jewish Hospital
Louisville, Kentucky, 40202
Medical Center of Central Georgia
Macon, Georgia, 31201
University of Miami Medical Center
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Ochsner Medical Center
New Orleans, Louisiana, 70121
Cornell University, New York - Presbyterian Hospital
New York, New York, 10065
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19140
Allegheny-Singer Research Institute - Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
VCU Medical Center
Richmond, Virginia, 23298
University of California San Francisco
San Francisco, California, 94143
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
St. Louis Heart and Vascular
St Louis, Missouri, 63136
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: C-Pulse Heart Assist Device pivOtal stUdy treatiNg paTients With modERate to Severe Heart Failure C-Pulse® System: A Heart Assist Device Pivotal IDE Study
Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse® System ("C-Pulse").
The purpose of the study is to determine whether the use of the C-Pulse as a treatment for patients in moderate to severe heart failure (HF) has demonstrated safety and efficacy, such that the C-Pulse System merits Food and Drug Administration (FDA) approval to market the device in the United States.
Read the detailed description
The C-Pulse® System is indicated for use in patients with moderate to severe heart failure while on optimal heart failure drug and on device therapies. The C-Pulse® System is intended to relieve the symptoms of heart failure, improve quality of life and cardiac function, and reduce the need for heart failure hospitalization. It is intended for use in hospital and at home. It is not intended as a replacement for heart function; it is not life sustaining or life-supporting therapy. It does not preclude the use of other heart failure therapies, such as valve surgery, heart transplantation or LVAD.
The Sunshine Heart C-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device. The system provides cardiac assistance through an extra-aortic balloon Cuff and ECG sense lead connected by means of a Percutaneous Interface Lead (PIL) to an external pneumatic Driver. The PIL is held secure externally, at the exit site, with a simple adhesive clip (C-Patch or similar) for immobilization of the external part of the PIL. The Driver is adjusted using a dedicated notebook computer (Programmer) with specialized software.
The non-blood contacting feature of the C-Pulse® System also allows the device to be intermittently turned off as tolerated. This allows the patient freedom for personal hygiene.
- Conditions
- Heart Failure
- Being tested
- C-Pulse® System Counterpulsation
- Keywords
- NYHA III, NYHA IV, ACC Stage C, Heart Failure, Congestive Heart Failure, C-Pulse, Counterpulsation, Heart Assist, Sunshine Heart, Left Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Pulse® System CounterpulsationDevice
The Sunshine Heart C-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device. The system provides cardiac assistance through an extra-aortic balloon Cuff and ECG sense lead connected by means of a Percutaneous Interface Lead (PIL) to an external pneumatic Driver. The PIL is held secure externally, at the exit site, with a simple adhesive clip (C-Patch or similar) for immobilization of the external part of the PIL. The Driver is adjusted using a dedicated notebook computer (Programmer) with specialized software.
| Study group | Role | What they receive |
|---|---|---|
| C-Pulse® System | Experimental | C-Pulse® System Counterpulsation Receives: Device: C-Pulse® System Counterpulsation |
| Control Arm | No intervention | Optimal Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome
The primary safety endpoint is serious procedure and device related adverse events as determined by CEC adjudication. No formal statistical hypotheses.
Measured: 4 Years Follow-up
Secondary outcomes (3)
Improvement in 6 Minute Hall Walk (6MW) at 12-months
improvement of distance walked during the 6MW at 12-months.
Measured: 12-months
Improvement in LVEF at 12 Months.
Improvement in left ventricular ejection fraction (LVEF) at 12 months.
Measured: 12-months
Improvement in KCCQ Score at 12-months.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a quality-of-life assessment for heart failure patients taking into consideration severity of heart failure symptoms and limitations patients experience. The scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study start12 Sep 2012
- Primary completion19 Sep 2018
- Study completion26 Oct 2018
Why it stopped: The study was stopped early due to a business decision to no longer pursue commercialization of the C-PULSE System. This decision was not based on any safety concerns.
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuwellis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Abraham, MD, Principal investigator, Ohio State UniversityMargarita T Camacho, MD, Principal investigator, Newark Beth Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740596
- Sponsor's protocol ID
- PRO 03970-C
- Acronym
- COUNTER-HF
- Status last verified
- Aug 2023
- First submitted
- 28 Nov 2012
- Last updated
- 11 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-Pulse Heart Assist Device pivOtal stUdy treatiNg paTients With modERate to Severe Heart Failure C-Pulse® System: A Heart Assist Device Pivotal IDE Study
- ClinicalTrials.gov ID
- NCT01740596
- Acronym / sponsor ID
- COUNTER-HF / PRO 03970-C
- Conditions
- Heart Failure
- Keywords
- NYHA III, NYHA IV, ACC Stage C, Heart Failure, Congestive Heart Failure, C-Pulse, Counterpulsation, Heart Assist
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped early due to a business decision to no longer pursue commercialization of the C-PULSE System. This decision was not based on any safety concerns.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Nuwellis, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2012 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Posted 11 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse® System ("C-Pulse").
The purpose of the study is to determine whether the use of the C-Pulse as a treatment for patients in moderate to severe heart failure (HF) has demonstrated safety and efficacy, such that the C-Pulse System merits Food and Drug Administration (FDA) approval to market the device in the United States.
Detailed description
The C-Pulse® System is indicated for use in patients with moderate to severe heart failure while on optimal heart failure drug and on device therapies. The C-Pulse® System is intended to relieve the symptoms of heart failure, improve quality of life and cardiac function, and reduce the need for heart failure hospitalization. It is intended for use in hospital and at home. It is not intended as a replacement for heart function; it is not life sustaining or life-supporting therapy. It does not preclude the use of other heart failure therapies, such as valve surgery, heart transplantation or LVAD.
The Sunshine Heart C-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device. The system provides cardiac assistance through an extra-aortic balloon Cuff and ECG sense lead connected by means of a Percutaneous Interface Lead (PIL) to an external pneumatic Driver. The PIL is held secure externally, at the exit site, with a simple adhesive clip (C-Patch or similar) for immobilization of the external part of the PIL. The Driver is adjusted using a dedicated notebook computer (Programmer) with specialized software.
The non-blood contacting feature of the C-Pulse® System also allows the device to be intermittently turned off as tolerated. This allows the patient freedom for personal hygiene.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-Pulse® System | Experimental | Device: C-Pulse® System CounterpulsationC-Pulse® System Counterpulsation |
| Control Arm | No intervention | –Optimal Medical Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Left ventricular ejection fraction (LVEF) ≤ 35% (by transthoracic ECHO within 90 days prior to randomization)
- ACC/AHA Stage C and NYHA III to ambulatory Class IV
- Age ≥ 18 years
- Must have cardiac resynchronization therapy (CRT) when clinically indicated, implanted ≥90 days prior to randomization.
- Must have an implanted cardio-defibrillator (ICD) when clinically indicated, implanted at least 30 days prior to randomization.
Key exclusion criteria (27 listed)
- Any evidence, as assessed within 90 days prior to enrollment, of either:
- Aorta not conforming to specified dimensional constraints defined by CT scan, most specifically mid ascending aortic outside diameter less than 28 mm or greater than 42 mm
- Inotrope dependence - inability to wean from inotropic therapy
- ACC/AHA Stage D heart failure or non-ambulatory NYHA Class IV subject
- Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, diastolic heart failure or technically challenging congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-Pulse® System CounterpulsationThe Sunshine Heart C-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device. The system provides cardiac assistance through an extra-aortic balloon Cuff and ECG sense lead connected by means of a Percutaneous Interface Lead (PIL) to an external pneumatic Driver. The PIL is held secure externally, at the exit site, with a simple adhesive clip (C-Patch or similar) for immobilization of the external part of the PIL. The Driver is adjusted using a dedicated notebook computer (Programmer) with specialized software. | Device | C-Pulse® System |
Primary outcome
Primary Safety Outcome
Time frame: 4 Years Follow-up
The primary safety endpoint is serious procedure and device related adverse events as determined by CEC adjudication. No formal statistical hypotheses.
3 secondary outcomes
Improvement in 6 Minute Hall Walk (6MW) at 12-months
Time frame: 12-months
Improvement in LVEF at 12 Months.
Time frame: 12-months
Improvement in KCCQ Score at 12-months.
Time frame: 12-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William Abraham, MD principal investigator
Ohio State University
Margarita T Camacho, MD principal investigator
Newark Beth Israel
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Pulse® System Counterpulsation in people with Heart Failure, run by Nuwellis, Inc. at 28 sites in United States.
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 21 inclusion and 27 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: stopped early, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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 11 Jan 2024). 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?
Primary Safety Outcome (time frame: 4 Years Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2024.