ACTRN12610000656033
Completed
未知
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 enrollmentAugust 11, 2010
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sunshine Heart Inc
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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Unknown
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