Pace and diagnose in suspected cardiomyopathy
| ISRCTN | ISRCTN13249878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13249878 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 357728 |
| Protocol serial number | Nil known |
| Sponsor | University Hospitals Sussex NHS Foundation Trust |
| Funder | University Hospitals Sussex NHS Foundation Trust |
- Submission date
- 06/10/2025
- Registration date
- 14/11/2025
- Last edited
- 02/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The study aims to evaluate the technical feasibility and performance of lead-in-sheath endomyocardial (heart tissue) biopsy in possible cardiac sarcoidosis and cardiac amyloidosis.
Who can participate?
Adult patients >18 years of age undergoing Cardiac Implantable Electronic Device (CIED) implant, with clinically suspected cardiac sarcoidosis or amyloidosis
What does the study involve?
The study involves heart tissue biopsy using two methods. One method is the standard of care bioptome (tiny forceps), which takes a small sample of heart tissue during a pacemaker procedure. The second method is using a non-standard of care pacing lead to take a small sample of heart tissue. All samples will be sent to Royal Papworth Hospital for analysis and to try and identify a cause for the patient's heart disease.
What are the possible benefits and risks of participating?
The main benefit of the study is that, rather than just treating the patient’s abnormal heart rhythm or heart pump failure, it may actually identify an underlying cause of their heart disease. The conditions being investigated have specific treatments that can prevent disease progression and reduce the risk of life-threatening complications.
The first possible risk is the exposure to ionising radiation. But the IRMER guidelines ensure that radiation exposure is kept as low as reasonably practicable, safeguarding both patients and healthcare professionals. Another risk is temporary conduction disturbance (slow heart rhythms). These patients will be undergoing
pacemaker procedures, and therefore, the ability to provide temporary pacing is immediately available. In patients with signs of particular rhythm issues, which place them at higher risk of this occurring (‘left bundle branch block’ seen on the electrogram before starting), a pacemaker lead can be placed to provide support before taking biopsies. The final risk is pericardial bleed (bleeding in the space around the heart). Patients will be monitored closely for any signs of this during and after the procedure on the heart day case unit. If this were to occur, it can be treated by placing a drain from under the breastbone using ultrasound and local anaesthetic. Usually, the leak seals itself in under 24 hours, and the drain is removed. In the procedure, biopsies will be guided by a long, thin tube or sheath onto the safest part of the heart to take samples, reducing the risk of causing a bleed.
Where is the study run from?
The Clinical Research Facility at University Hospital Sussex NHS Foundation Trust, UK.
When is the study starting and how long is it expected to run for?
July 2025 to July 2027. Recruitment is aimed to last 18 months with the patients having a 4-6 month follow up as per standard of care.
Who is funding the study?
The University Hospitals Sussex NHS Foundation Trust's internal My UHSx Doctoral Fellowships Programme, UK.
Who is the main contact?
john.hildred1@nhs.net
Contact information
Public, Scientific, Principal investigator
University Hospital Sussex NHS Foundation Trust
Brighton
BN2 5BE
United Kingdom
| Phone | +44 (0)1273696955 |
|---|---|
| rebecca.godfrey@nhs.net |
Principal investigator
Sussex Cardiac Centre, Royal Sussex County Hospital, Eastern Road
Brighton
BN2 5BE
United Kingdom
| Phone | +44 (0)1273 696955 |
|---|---|
| john.silberbauer@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-site proof-of-principle study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Lead-in-sheath endomyocardial biopsy: a prospective cohort study evaluating and advancing this technique in suspected cardiac sarcoidosis and amyloidosis |
| Study objectives | Primary: - To evaluate the technical feasibility and performance of lead-in-sheath EMB in possible cardiac sarcoidosis and cardiac amyloidosis Secondary: - To compare the safety of concurrent EMB with standalone CIED implant - To assess if performing EMB influences the working diagnosis or treatment plan for patients - To correlate non-invasive cardiovascular magnetic resonance (CMR) scans, Electroanatomic Mapping (EAM), and pacing parameters (sensed unipolar electrogram, and paced ECG) with EMB findings to characterise location and depth |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Patients with suspected cardiac sarcoidosis and or cardiac amyloidosis |
| Intervention | 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 Biopsy in patients with suspected cardiac sarcoidosis and cardiac amyloidosis (Non Standard of Care) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Successful endomyocardial biopsy (EMB) using the lead-in-sheath method, defined as yielding myocardial tissue, measured during pathology analysis post procedure |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Patient undergoing Cardiac Implantable Electronic Device (CIED) implant, with clinically suspected cardiac sarcoidosis or amyloidosis 2. Indication for EMB |
| Key exclusion criteria | 1. Unable to give informed consent 2. Age <18 3. Pregnant or breastfeeding 4. Current participation in another interventional research study |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 01/07/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Lyndhurst Road
Worthing
BN11 2DH
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/12/2025: Contact details updated.
07/10/2025: Study's existence confirmed by the University Hospitals Sussex NHS Foundation Trust, UK.
