None listed
Conditions
Brief summary
The C-Pulse System is a new Heart Assist Device that is currently being studied in seven hospitals in the United States under the Food and Drug Administration (FDA) guidelines
Interventions
Sunshine Heart Inc. is sponsoring a prospective, multi-center trial to assess the safety and provide indications for performance of the Sunshine Heart C-Pulse TM System.
Sunshine Heart, Inc has proposed C-Pulse (TM), a novel ambulatory, non-obligatory, non-blood contacting extra-ascending aortic counterpulsation system. The C-Pulse (TM) System is designed to be implanted without the need for cardiopulmonary bypass or extensive dissection, to be able to be activated immediately, to augment hear
Sunshine Heart Inc. is sponsoring a prospective, multi-center trial to assess the safety and provide indications for performance of the Sunshine Heart C-Pulse TM System. Sunshine Heart, Inc has proposed C-Pulse (TM), a novel ambulatory, non-obligatory, non-blood contacting extra-ascending aortic counterpulsation system. The C-Pulse (TM) 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 (TM) 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 Left Ventricular Assist Devices (LVADs). The C-Pulse (TM) 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 Electrocardiography (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 (TM) 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. The surgical procedure for implanatation may take 2 -4 hours. For the study, patients are required to be connected to the C-Pulse System for approximately 20 hours a day. The patient can safely turn the device on and off as required to perform functions of daily living, such as personal hygiene. It is acceptable to switch the device off for up to 15 minutes.
Sponsors
Sunshine Heart Inc
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient has ACC/AHA Stage C heart failure and remains in NYHA Class III - ambulatory Class IV despite optimal medical therapy. 2. Patient has left ventricular ejection fraction less than or equal to 35% 3. Patient has had Cardiac Resynchronization Therapy (CRT) for at least 90 days prior to enrolment or is not indicated for a CRT device 4. Patient has had an implanted cardio–defibrillator (ICD) at least 30 days prior to enrolment or is not indicated for ICD implantation 5. Patient is at least 18 years of age and not older than 75 years 6. Patient six minute hall walk assessment between 100–350 meters 7. 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
Exclusion criteria
1. Patient has any evidence of : a. ascending aortic calcification on posterior–anterior or lateral chest x–ray OR b. has atherosclerotic ascending aortic disease, specifically intimal thickening greater than 3mm or mobile atheroma (moderate) or mural calcification (severe) 2. 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 3. Patient aorta not conforming to specified dimensional constraints defined by Computer Tomography (CT) scan, most specifically mid ascending aortic outside diameter less than 29mm or greater than 40mm 4. Patient has severe mitral valve incompetence, grade 4+ 5. Patient has moderate to severe aortic valve incompetence, grade 2–4+ 6. Patient has systolic blood pressure less than 90 or greater than 140 mmHg 7. Patient has a Serum Sodium less than 130 mEq/L 8. Patient has a Estimated Glomelular Filtrate Rate (GFR) less than 40 ml/min/1.73 m2 9. Patient has any two of three of Bilirubin, aspartate aminotransferase enzyme (AST), alanine transaminase enzyme (ALT) greater than 3 times upper limit of normal for each institution 10. Patient has a serum Albumin less than 3.0 g/dL 11. Patient has Body Mass Index (BMI) less than 18 or greater than 40 kgm2 12. Men with Peak VO2 of greater than 18ml/kg/min or less than 10 ml/kg/min 13. Women with Peak VO2 of greater than 16 or less than 9 ml/kg/min 14. Patient has any active infection 15. Patient has had a myocardial infarction, stroke, transient ischemic attack, cardiac or other major surgery, in the 3 months prior to study enrollment. 16. Patient has severe Chronic Obstructive Pulmonary Disease (COPD) as evidenced by Forced Expiratory Volume (FEV1) less than or equal to 0.9 L/min 17. Patient requires a concomitant surgical procedure (i.e. Cornonary Artery Bypass Graft (CABG), Valve repair) 18. Patient is supported with a left ventricular assist device or intra–aortic balloon pump. 19. Severe right heart dysfunction with systemic venous congestion evidenced by clinical signs/symptoms such as Central Venous Pressure (CVP) greater than or equal to 20 mmHg , Cardiac Index < 2.0 l/min/m2, elevated liver function tests beyond three times the upper limit of normal with the presence of ascites. 20. Patient has reversible causes of heart failure that may be remedied by conventional surgery or other intervention 21. Patient is pregnant. Note: Negative pregnancy test required in all women of child bearing potential. 22. 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 23. 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 or affect study outcome 24. Patient has symptomatic Carotid artery disease or asymptomatic disease with a stenosis greater than 70% as determined by Carotid Doppler Ultrasound.
Outcome results
None listed