Controlled trial of High-risk coronary Intervention with Percutaneous left ventricular unloading
King's College London
Duration of Study in the UK
4 years, 11 months, 30 days
Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel and a stent is inserted to keep the vessel open, are performed every year in the UK 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 the heart becoming unable to pump blood properly during the procedure. This is a serious complication called heart failure 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 pump which is placed in the heart’s main chamber (the left ventricle, LV) to support the heart muscle to pump blood around the body. This pump is known as an LV unloading device. The LV unloading device is inserted into the heart through a blood vessel in the leg. 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 £8,000 per operation. Currently, there is no strong evidence to guide the use of this device.
The CHIP 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.
To do so, CHIP will enrol 250 participants across England, Scotland and Northern Ireland and randomise them to either receive a LV unloading device with their stenting procedure or receive their stenting procedure as usual.
London - Bloomsbury Research Ethics Committee
Date of REC Opinion
12 May 2021
Further Information Favourable Opinion