C-PulseĀ® System European Multicenter Study (NCT01872949) | Clinical Trial Compass
CompletedNot Applicable
C-PulseĀ® System European Multicenter Study
Austria, Germany15 participantsStarted 2014-01-13
Plain-language summary
The study is designed to observe the clinical outcomes of heart failure patients treated with C-PulseĀ® System in the usual manner and according to the approved indications and contraindications.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is 18 years or older
* Patients with moderate to severe ambulatory heart failure \[American College of Cardiology/American Heart Association (ACC/AHA) Stage C; NYHA Class III/IV ambulatory\], who are refractory to optimal medical therapy
* Patients who are non-responders to CRT pacemaker therapy
* Patient has signed and dated the investigation informed consent form
Exclusion Criteria:
* Evidence of significant ascending aortic calcification on postero-anterior chest X-ray or CT scan
* Moderate or severe atherosclerotic aortic disease
* Ascending aorto-coronary artery bypass grafts
* Any history of aortic dissection
* Connective tissue disorder such as Marfans disease
* Aorta not conforming to specified dimensional constraints
* Patient has severe mitral valve incompetence, grade 4+
* Patient has moderate to severe aortic valve incompetence, grade 2 - 4+
* Patient has systolic blood pressure less than 90 or greater than 140mmHg
* Presence of active systemic infection
* Presence of bleeding or coagulation disorder (relative)