Sunshine Heart C-Pulse Sub-study
Research type
Research Study
Full title
Supplementary site-specific investigation of the clinical performance of the Sunshine Heart C-Pulse system
IRAS ID
142209
Contact name
Andre Simon
Contact email
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust
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. In contrast to advanced forms of treatment for heart failure, such as implantable artificial hearts, the C-Pulse is intended for the treatment of patients at an earlier stage in the disease process with the aim of increasing exercise capacity and 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 artificial heart therapy.
Preliminary evidence of safety and efficacy of the C-Pulse has already been demonstrated in clinical studies 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. This requirement is the basis of a multi-centre study currently underway in Europe, in which the Harefield team are participating, following ethical approval by NRES London Stanmore.
Participation in the aforementioned study provides an opportunity to gain an additional insight into the performance of the the C-Pulse system. In this supplementary study we propose to i) compare the performance of the C-Pulse to an established short term of circulatory support ii) perform extra echocardiographical tests (ultrasound of the heart) to see how heart function changes with the C-Pulse iii) monitor changes in the exercise capacity of C-Pulse recipients and iv) measure novel blood biomarkers (e.g. microRNAs) before and during C-Pulse support that might improve future patient selection for the C-Pulse.
REC name
London - Stanmore Research Ethics Committee
REC reference
14/LO/1093
Date of REC Opinion
15 Jul 2014
REC opinion
Favourable Opinion