Patients with suspected cardiac sarcoidosis and or cardiac amyloidosis Circulatory System
Conditions
Interventions
Using a Bioptome to take an Endomyocardial Biopsy sample in patients suspected of having Cardiac Sarcoidosis or Cardiac Amyloidosis (Standard of Care)
Using a Lead in Sheath method for Endomyocardial
Sponsors
University Hospitals Sussex NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient undergoing Cardiac Implantable Electronic Device (CIED) implant, with clinically suspected cardiac sarcoidosis or amyloidosis 2. Indication for EMB
Exclusion criteria
Exclusion criteria: 1. Unable to give informed consent 2. Age <18 3. Pregnant or breastfeeding 4. Current participation in another interventional research study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Safe EMB, defined as no increase in adverse event rate, when compared with standalone CIED implant, measured by monitoring the adverse event rate at 4-6 months follow-up 2. Change in working diagnosis and treatment plan measured using patient clinical history and medication review following EMB at 4-6 month follow-up 3. Correlation of pacing parameters and multi-parametric non-invasive CMR imaging, and EAM (mapped voltage and frequency) abnormalities with EMB findings to characterise location and depth measured after the procedure | — |
Primary
| Measure | Time frame |
|---|---|
| Successful endomyocardial biopsy (EMB) using the lead-in-sheath method, defined as yielding myocardial tissue, measured during pathology analysis post procedure | — |
Countries
England, United Kingdom
Contacts
Public ContactRebecca;John Godfrey;Silberbauer
;
Outcome results
None listed