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Contact Information:

Trial Manager 020 7927 2723
CHIP-BCIS3@LSHTM.ac.uk


Matt Ryan matthew.ryan@kcl.ac.uk


Study Location:

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Be Part of Research - Trial Details - Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading

Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Coronary Artery Disease
Myocardial Ischemia
Heart Diseases


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel, are performed every year in the United Kingdom to treat people who have conditions such as angina or have suffered a heart attack.

For most patients the risk of complications is low, but for some, there is a higher risk of their heart failing during the procedure. Heart failure is a serious complication which can need treatment with a life support machine and lead to major damage to the heart muscle or even death. These risks are greatest in patients with severely diseased heart arteries and those who already have weakened heart muscle.

A new technology may be able to help with this problem. It consists of a small heart pump which is placed in the heart's main pumping chamber (the left ventricle, LV). This pump is known as a LV unloading device. The LV unloading device is inserted into the heart through a blood vessel in the leg and supports the heart muscle. It is removed at the end of the procedure or when the heart can pump safely on its own. Whilst this heart pump is promising, it comes with some risks of its own. These include bleeding and damage to the arteries in the legs. It is also expensive, costing ÂŁ8,000 per operation. Currently, there is no strong evidence to guide the use of this device.

The CHIP-BCIS3 study aims to determine whether these heart pumps are beneficial and cost-effective in patients receiving a stenting procedure who are at high-risk of complications.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2021 Jun 2025

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : Percutaneous left ventricular unloading involves the placement of a mechanical pump which draws blood from the left ventricle and returns it into the aorta at flow rates approaching native cardiac output.

Intervention Arm Group : LV-unloading;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Guy's and St Thomas' NHS Foundation Trust
    London
    SE1 7EH


The study is sponsored by Guy's and St Thomas' NHS Foundation Trust and is in collaboration with London School of Hygiene and Tropical Medicine; The Queen Elizabeth Hospital; The Royal Bournemouth Hospital; St. George's Hospital, London; King's College Hospital, London; King's College London; Royal Victoria Hospital, Belfast; Bristol Heart Institute; Leeds General Infirmary; Freeman Hospital, Newcastle; Barts Heart Centre, London; Glenfield Hospital, Leicester; Morriston Hospital, Swansea; St Thomas' Hospital, London; Royal Sussex County Hospital; New Cross Hospital, Wolverhampton.




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Read full details for Trial ID: NCT05003817
Last updated 24 July 2024

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