Heart FailureNCT01176370
C-Pulse Implantable Counterpulsation Pump (ICP) - A Heart Assist Device
A study testing C-Pulse™ (Implantable Counterpulsation Therapy) in people with Heart Failure, run by Nuwellis, Inc. at 1 site in Canada.
Trial summary
The C-Pulse Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily activities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- C-Pulse™ (Implantable Counterpulsation Therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jun 2010to 30 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has ACC/AHA Stage C heart failure and remains in NYHA Class III - ambulatory Class IV despite optimal medical therapy.
- ACE inhibitor or ARB (Angiotensin Receptor Blocks) at least 30 days preceding implant or nitrate/hydralazine at the investigators discretion
- Beta-blocker for at least 90 days and stable for 30 days preceding implant
- Patient has left ventricular ejection fraction (LVEF) ≤ 35%
- Patient has had Cardiac Resynchronization Therapy (CRT) for at least 90 days prior to enrollment or is not indicated for a CRT device
- Patient has had an implanted cardio-defibrillator (ICD) at least 30 days prior to enrollment or is not indicated for ICD implantation.
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- Patient is at least 18 years of age and not older than 75 years
- Patient six minute hall walk assessment between 100-350 meters
- Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provide written informed consent prior to the procedure
Who cannot join
- Patient has any evidence of:
- Ascending aortic calcification on posterior-anterior or lateral chest x-ray at initial screening OR
- Atherosclerotic ascending aortic disease, specifically intimal thickening greater than 3mm or mobile atheroma (moderate) or mural calcification (severe) as detected by CT scan or echocardiography (Echo)
- Patient has ascending aorto-coronary artery bypass grafts, history of aortic dissection, Marfans disease or other connective tissue disorder or has had an aortic root replacement
- Patient aorta not conforming to specified dimensional constraints defined by CT scan, most specifically mid ascending aortic outside diameter less than 29mm or greater than 40mm
- Patient has severe mitral valve incompetence, grade 4+
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- Patient has moderate to severe aortic valve incompetence, grade 2-4+
- Patient has systolic blood pressure less than 90 or greater than 140 mmHg
- Patient has a Serum Sodium less than 130 mEq/L
- Patient has a Estimated Glomerular Filtration Rate (GFR) less than 40 ml/min/1.73m2
- Patient has any two of three of Bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) greater than three times upper limit of normal
- Patient has a serum Albumin less than 3.0 g/dL
- Patient has Body Mass Index (BMI) less than 18 or greater than 40 kg/m2
- Patient has any active infection
- Patient has had a myocardial infarction (MI), stroke, transient ischemic attack (TIA), cardiac or other major surgery, in the 90 days prior to enrollment
- Patient has severe Chronic Obstructive Pulmonary Disease (COPD) as evidenced by Forces Expiratory Volume (FEV1) less than or equal to 0.9 L/min
- Patient requires a concomitant surgical procedure [i.e. coronary artery bypass graft (CABG), Valve repair]
- Patient is supported with a left ventricular assist device or IABP
- Severe Right Heart Dysfunction with systemic venous congestion evidenced by clinical signs/symptoms such as Central Venous Pressure (CVP) ≥ 20 mmHg, Cardiac Index (CI) < 2.0 l/min./m2, elevated liver function tests beyond three time the upper limit of normal and presence of ascites
- Patient has reversible causes of heart failure that may be remedied by conventional surgery or other intervention
- Patient is pregnant; Note: Negative pregnancy test required in all women of child bearing potential
- Patient has any other condition that, in the opinion of the investigators, would disqualify the patient for inclusion in the study, limits survival to less than one year, or not permit valid consideration
- Patient is currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study that is likely to confound study results
- Patient has symptomatic Carotid artery disease or asymptomatic disease with a stenosis greater than 70%.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre - Royal Victoria Hospital
Montreal, Quebec, QcH3A 1A1
About this study
Official title: A Prospective Study to Assess the Safety and Indications of Performance of the C-Pulse™ System in Relieving Heart Failure Symptoms in Patients With ACC/AHA Stage C, NYHA Class III-ambulatory Class IV Heart Failure.
The C-Pulse Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily activities. The study evaluates multiple measures of heart function and whether the patient's quality of life has been improved since the device implant. The patient will have several visits after the device implant to assess how well they are doing and to monitor any safety concerns.
Read the detailed description
Sunshine Heart Inc. is sponsoring a prospective trial to assess the safety and provide indications for performance of the Sunshine Heart C-PulseTM System ("C-Pulse™").
The current need is for a counterpulsation device or method that is effective enough to make its application appealing as a long-term implant to a large number of patients and physicians. It must be simple and safe, with a straight-forward implant procedure, and with long-term measurable patient benefits. Further, it would be advantageous for the counterpulsation device to be smaller, easier to insert, ambulatory, disconnectable, and not in the bloodstream. Such a device may be more readily adopted by a wider group of cardiologists and surgeons, and be suitable for a wider group of people in NYHA Class III or IV heart failure. It is important to point out that a counterpulsation device is aimed to augment native heart function and is fundamentally different from total artificial hearts, left ventricular assist devices and heart transplants which are meant to be a total replacement or an alternative to the native heart. Thus, the counterpulsation device is considered non-obligatory and not life-supporting.
Sunshine Heart, Inc has proposed C-Pulse™, a novel ambulatory, non-obligatory, non-blood contacting extra-ascending aortic counterpulsation system. The C-Pulse™ System is designed to be implanted without the need for cardiopulmonary bypass or extensive dissection, to be able to be activated immediately, to augment heart function in a safe manner and to provide sustained relief from heart failure symptoms. It can be turned off safely, and similarly, in failure modes, is considered to have an associated low risk of death or disability, other than the recurrence of heart failure symptoms. C-Pulse™ is not an alternative to the heart, it is an augmentation device, and it does not preclude the use of therapies that provide full circulatory support such as heart transplantation or LVADs.
The C-Pulse™ System consists of a counterpulsation Cuff secured around the outside of the ascending aorta, the main blood vessel out of the heart. The Cuff and a heart signal sensing wire are attached to an external driver. The external Driver inflates and deflates the Cuff in sequence with the ECG signal to assist heart function and improve the pumping capacity of the heart. The Cuff deflects the aorta in a "thumb-printing" manner which has been optimized to minimize aortic wall strain and maximize blood volume displacement per beat. The C-Pulse™ System is non-blood contacting, simple to insert, and can be turned on and off as required; all natural blood pathways are maintained - there is no exposure of foreign material to the bloodstream.
- Conditions
- Heart Failure
- Being tested
- C-Pulse™ (Implantable Counterpulsation Therapy)
- Keywords
- Heart Failure, Device, Implantable, Active, Class III and Class IV, Counterpulsation
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Pulse™ (Implantable Counterpulsation Therapy)Device
Also called C-Pulse, Implantable Counterpulsation Pump, Heart Assist System, Sunshine Heart C-Pulse ICP
C-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device.
| Study group | Role | What they receive |
|---|---|---|
| Implantable Counterpulsation Therapy | Experimental | The study is a single arm study with up to 20 patients enrolled and implanted with implantable counterpulsation. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. There is not a control arm in this feasibility study. Receives: Device: C-Pulse™ (Implantable Counterpulsation Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients with a Device-Related Adverse Event
The primary safety endpoint is the composite device-related adverse event rate as defined by the percent of patients who experience at least one device-related adverse events out of the total number of patients.
Measured: Through 6 months
Quality of Life (QOL)
improvement from baseline to 6-months post-implant. QOL as measured by the Minnesota Living with Heart Failure (MLWHF) questionnaire.
Measured: 6 months
New York Heart Association (NYHA) Classification
improvement from baseline to 6-months post-implant. 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
Improvement in 6 Minute Walk Test (6MWT)
improvement from baseline to 6-months post-implant. 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
Secondary outcomes (1)
Further assess risks and benefits
Endpoints consistent with primary outcomes will be evaluated at additional time points and device failure rate and adverse event rates will be assessed.
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study start21 Jun 2010
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Why it stopped: Enrollment for this study was stopped following approval of the C-Pulse System pivotal study IDE.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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled/consented subjects receive study device: C-Pulse™ (Implantable Counterpulsation Therapy).
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuwellis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renzo Cecere, MD, Principal investigator, McGill University Health Centre, Royal Victoria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176370
- Sponsor's protocol ID
- PRO 02977 Rev - B
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2010
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Assess the Safety and Indications of Performance of the C-Pulse™ System in Relieving Heart Failure Symptoms in Patients With ACC/AHA Stage C, NYHA Class III-ambulatory Class IV Heart Failure.
- ClinicalTrials.gov ID
- NCT01176370
- Acronym / sponsor ID
- PRO 02977 Rev - B
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Device, Implantable, Active, Class III and Class IV, Counterpulsation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment for this study was stopped following approval of the C-Pulse System pivotal study IDE.This decision was not based on any safety concerns.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Nuwellis, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2010 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The C-Pulse Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily activities. The study evaluates multiple measures of heart function and whether the patient's quality of life has been improved since the device implant. The patient will have several visits after the device implant to assess how well they are doing and to monitor any safety concerns.
Detailed description
Sunshine Heart Inc. is sponsoring a prospective trial to assess the safety and provide indications for performance of the Sunshine Heart C-PulseTM System ("C-Pulse™").
The current need is for a counterpulsation device or method that is effective enough to make its application appealing as a long-term implant to a large number of patients and physicians. It must be simple and safe, with a straight-forward implant procedure, and with long-term measurable patient benefits. Further, it would be advantageous for the counterpulsation device to be smaller, easier to insert, ambulatory, disconnectable, and not in the bloodstream. Such a device may be more readily adopted by a wider group of cardiologists and surgeons, and be suitable for a wider group of people in NYHA Class III or IV heart failure. It is important to point out that a counterpulsation device is aimed to augment native heart function and is fundamentally different from total artificial hearts, left ventricular assist devices and heart transplants which are meant to be a total replacement or an alternative to the native heart. Thus, the counterpulsation device is considered non-obligatory and not life-supporting.
Sunshine Heart, Inc has proposed C-Pulse™, a novel ambulatory, non-obligatory, non-blood contacting extra-ascending aortic counterpulsation system. The C-Pulse™ System is designed to be implanted without the need for cardiopulmonary bypass or extensive dissection, to be able to be activated immediately, to augment heart function in a safe manner and to provide sustained relief from heart failure symptoms. It can be turned off safely, and similarly, in failure modes, is considered to have an associated low risk of death or disability, other than the recurrence of heart failure symptoms. C-Pulse™ is not an alternative to the heart, it is an augmentation device, and it does not preclude the use of therapies that provide full circulatory support such as heart transplantation or LVADs.
The C-Pulse™ System consists of a counterpulsation Cuff secured around the outside of the ascending aorta, the main blood vessel out of the heart. The Cuff and a heart signal sensing wire are attached to an external driver. The external Driver inflates and deflates the Cuff in sequence with the ECG signal to assist heart function and improve the pumping capacity of the heart. The Cuff deflects the aorta in a "thumb-printing" manner which has been optimized to minimize aortic wall strain and maximize blood volume displacement per beat. The C-Pulse™ System is non-blood contacting, simple to insert, and can be turned on and off as required; all natural blood pathways are maintained - there is no exposure of foreign material to the bloodstream.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled/consented subjects receive study device: C-Pulse™ (Implantable Counterpulsation Therapy).
| Arm | Type | Receives |
|---|---|---|
| Implantable Counterpulsation Therapy | Experimental | Device: C-Pulse™ (Implantable Counterpulsation Therapy)The study is a single arm study with up to 20 patients enrolled and implanted with implantable counterpulsation. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. There is not a control arm in this feasibility study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient has ACC/AHA Stage C heart failure and remains in NYHA Class III - ambulatory Class IV despite optimal medical therapy.
- ACE inhibitor or ARB (Angiotensin Receptor Blocks) at least 30 days preceding implant or nitrate/hydralazine at the investigators discretion
- Beta-blocker for at least 90 days and stable for 30 days preceding implant
- Patient has left ventricular ejection fraction (LVEF) ≤ 35%
- Patient has had Cardiac Resynchronization Therapy (CRT) for at least 90 days prior to enrollment or is not indicated for a CRT device
Key exclusion criteria (24 listed)
- Patient has any evidence of:
- Patient has ascending aorto-coronary artery bypass grafts, history of aortic dissection, Marfans disease or other connective tissue disorder or has had an aortic root replacement
- Patient aorta not conforming to specified dimensional constraints defined by CT scan, most specifically mid ascending aortic outside diameter less than 29mm or greater than 40mm
- Patient has severe mitral valve incompetence, grade 4+
- Patient has moderate to severe aortic valve incompetence, grade 2-4+
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™ (Implantable Counterpulsation Therapy)Also: C-Pulse, Implantable Counterpulsation Pump, Heart Assist System, Sunshine Heart C-Pulse ICPC-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device. | Device | Implantable Counterpulsation Therapy |
Primary outcome
Percent of Patients with a Device-Related Adverse Event
Time frame: Through 6 months
The primary safety endpoint is the composite device-related adverse event rate as defined by the percent of patients who experience at least one device-related adverse events out of the total number of patients.
Quality of Life (QOL)
Time frame: 6 months
improvement from baseline to 6-months post-implant. QOL as measured by the Minnesota Living with Heart Failure (MLWHF) questionnaire.
New York Heart Association (NYHA) Classification
Time frame: 6 months
improvement from baseline to 6-months post-implant. 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
Improvement in 6 Minute Walk Test (6MWT)
Time frame: 6 months
improvement from baseline to 6-months post-implant. 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.
1 secondary outcome
Further assess risks and benefits
Time frame: 5-years
Results and safety
The study was stopped early (reason given: Enrollment for this study was stopped following approval of the C-Pulse System pivotal study IDE.This decision was not based on any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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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.
Renzo Cecere, MD principal investigator
McGill University Health Centre, Royal Victoria Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Pulse™ (Implantable Counterpulsation Therapy) in people with Heart Failure, run by Nuwellis, Inc. at 1 site in Canada.
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 9 inclusion and 24 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 15 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 1 site in Canada. 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?
The study was stopped early (reason given: Enrollment for this study was stopped following approval of the C-Pulse System pivotal study IDE.This decision was not based on any safety concerns.). Results are not available in the source record.
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?
Percent of Patients with a Device-Related Adverse Event (time frame: Through 6 months). The study lists 4 primary outcomes in all. 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 15 Aug 2023.