A prospective study to assess the safety and indications of performance of the C–Pulse Trademark (TM) System in relieving heart failure symptoms in patients with ACC/AHA Stage C, NYHA Class III-ambulatory Class IV heart failure.

Sunshine Heart Inc0 sites5 target enrollmentStarted: August 11, 2010Last updated: January 13, 2020

Trial Snapshot

Phase: 未知
Status: Completed
Sponsor
Enrollment: 5

Study Overview Study Design Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional
Allocation: Non-randomised trial
Primary Purpose: Treatment
Masking: Open (masking not used)

Eligibility Criteria

Ages: 18 Years to 75 Years (—)
Sex: All

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
•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.

Investigators

Sponsor

Sunshine Heart Inc

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