Prospective Evaluation Of Exercise-Induced Cardiac Conduction Instability In Predicting Ventricular Fibrillation Events In Hypertrophic Cardiomyopathy

Summary

Hypertrophic Cardiomyopathy (HCM) is an inherited heart condition. Most people who have it are unaware of any problems relating to it. Unfortunately, a small number of people with the condition can suddenly develop a dangerous fast heart beat that can lead to death. There is no cure, but implanting a cardioverter-defibrillator (ICD), which is like a pacemaker can save the life of affected individuals. However, ICD implantation has its own problems, so choosing who gets an ICD is a very important decision.

The current approach for recommending people for an ICD has limitations and a better method is needed. Investigators have developed a new technique called the 'Ventricular Conduction Stability' (V-CoS). This involves wearing a special vest which records electrical signals from the heart, and then running on a treadmill. Investigators have used it to identify abnormalities in the hearts of people with HCM who have also survived a life-threatening event.

This project aims to test new tool against current methods to ascertain which is better at identifying patients who should have an ICD.

Conditions

• Hypertrophic Cardiomyopathy

Interventions

DIAGNOSTIC_TEST

Non-invasive ECG imaging - CardioInsight test

1. Consent session 2. Fitting of ECGi vest and CT scan of the chest 3. Supervised exercise test and Valsalva maneuvre 4. Programmed stimulation via ICD (selected participants) 5. Blood tests - genetics

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• Medtronic

  collaborator INDUSTRY

• Barts & The London NHS Trust

  collaborator OTHER

• Daniel Bagshaw Trust

  collaborator UNKNOWN

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Brighton and Sussex University Hospitals NHS Trust

  collaborator OTHER

• University Hospital of Wales

  collaborator OTHER

• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• Imperial College London

  lead OTHER

Principal Investigators

• Prapa Kanagaratnam, FRCP, PhD · Imperial College NHS Trust

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-10

Primary Completion

2026-08-01

Completion

2026-12-01

FDA Device

Yes

Countries

• United Kingdom

Study Locations