Pace and diagnose in suspected cardiomyopathy
Research type
Research Study
Full title
Lead-in-sheath endomyocardial biopsy: a prospective cohort study evaluating and advancing this technique in suspected cardiac sarcoidosis and amyloidosis
IRAS ID
357728
Contact name
John Silberbauer
Contact email
Sponsor organisation
University Hospitals Sussex NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
As heart doctors we may recommend a pacemaker or defibrillator for patients with an abnormal slow or fast heat beat (‘arrhythmia’), or weak heart pump (‘heart failure’). This is to improve symptoms, and prolong life. We often do not know the cause for the heart disease.
It is possible to take a small (2-3mm) sample of tissue at the time of putting in the pacemaker. This has been done with the traditional equipment used to take a heart biopsy (tiny forceps called a 'bioptome'), and also with the pacemaker lead itself. The pacing sheath (a long thin tube) naturally directs either the lead or the bioptome to take a small sample safely, prior to placing the lead.
In these initial studies evaluating these techniques, the small sample taken at the time of inserting a pacemaker identified a cause for the heart disease in a significant number of patients. This allowed better treatment to be given, targeted to the underlying cause.
Some conditions which can affect the heart, and may be found when heart tissue is examined include ‘sarcoidosis’ (which causes inflammation in the heart) and ‘amyloidosis’ (which causes stiffness in the heart). If these conditions are found, specific treatment is often given. In cardiac sarcoidosis, inflammation is treated by steroids. In cardiac amyloidosis, a specific drug is given to limit further deposition of amyloid protein in the heart.
In this study, during a planned pacemaker procedure, eligible patients will have small samples of tissue taken using the pacemaker lead in addition to the bioptome - to assess how effective the lead biopsy technique is when cardiac sarcoidosis or amyloidosis are clinically suspected. Patients will have a follow up appointment 4-6 months following their procedure. This study will take place at University Hospitals Sussex NHS Foundation Trust.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
25/SW/0144
Date of REC Opinion
24 Nov 2025
REC opinion
Favourable Opinion