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

Summary

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 £8,000 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.

Conditions

• Ischemic Heart Disease
• Coronary Artery Disease

Interventions

DEVICE

Percutaneous left ventricular unloading

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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• The Queen Elizabeth Hospital

  collaborator OTHER

• The Royal Bournemouth Hospital

  collaborator OTHER

• St. George's Hospital, London

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• King's College London

  collaborator OTHER

• Royal Victoria Hospital, Belfast

  collaborator OTHER

• Bristol Heart Institute

  collaborator UNKNOWN

• Barts Heart Centre, London

  collaborator UNKNOWN

• Glenfield Hospital, Leicester

  collaborator OTHER

• Morriston Hospital, Swansea

  collaborator UNKNOWN

• St Thomas' Hospital, London

  collaborator OTHER

• New Cross Hospital, Wolverhampton

  collaborator UNKNOWN

• Essex Cardiothoracic Centre, Basildon

  collaborator UNKNOWN

• Freeman Hospital, Newcastle

  collaborator UNKNOWN

• Golden Jubilee National Hospital, Glasgow

  collaborator UNKNOWN

• John Radcliffe Hospital, Oxford

  collaborator UNKNOWN

• Manchester Royal Infirmary

  collaborator UNKNOWN

• Royal Cornwall Hospital, Truro

  collaborator UNKNOWN

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• Musgrove Park Hospital, Taunton

  collaborator UNKNOWN

• Royal Sussex County Hospital, Brighton

  collaborator UNKNOWN

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Divaka Perera · KCL, GSTT

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-06

Primary Completion

2025-12-03

Completion

2026-06-30

Countries

• United Kingdom

Study Locations