Multi-centre Sunshine Heart C-Pulse Study
Research type
Research Study
Full title
C-Pulse® System: European Multicentre Study
IRAS ID
133480
Contact name
Andre R Simon
Contact email
Sponsor organisation
Sunshine Heart Inc
Clinicaltrials.gov Identifier
Research summary
The Sunshine Heart C-Pulse® is a new treatment for patients whose hearts cannot pump enough blood around the body, a life-threatening and debilitating medical condition known as heart failure. Current treatment options for this condition include medicines, pacemakers and heart surgery. Alternatively, implantable blood pumps known as Left Ventricular Assist Devices (LVADs) can be used to support the circulation but this entails a major operation usually only offered to the worst-affected patients. There are significant risks associated with LVAD therapy which relate primarily to the need for direct blood contact with the device. In contrast, the C-Pulse is intended for the treatment of patients with less severe, though serious heart failure with the aim of increasing exercise capacity, improving quality of life. In contrast to other types of mechanical circulatory support, the C-Pulse is not in direct contact with the blood; it acts by gently squeezing the main artery arising from the heart with the aim of avoiding many of the complications of LVAD therapy.
Preliminary evidence of safety and efficacy of the C-Pulse has already been demonstrated in studies in the US, Australia and New Zealand and the device is CE marked (i.e.. it has regulatory approval in Europe). However, a need has been identified to collect more clinical data in order to confirm the findings of earlier studies and provide further evidence of patient benefit.
In the proposed study, safety will be assessed by recording any adverse events which occur. Device performance will be assessed by determining the changes in important clinical parameters (such as blood pressure and improvements in the patients’ quality of life).
The study, which has already commenced in Germany, will enrol 50 patients in 10 European centres in patients with moderate to severe heart failure. The study is expected to finish enrolment in December 2015.
REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/1847
Date of REC Opinion
10 Dec 2013
REC opinion
Favourable Opinion