Physiological Biomarkers For Implantable Cardioverter-Defibrillators
Research type
Research Study
Full title
Development of physiological biomarkers for implantable cardioverter defibrillators to allow patient specific therapies
IRAS ID
247788
Contact name
Zachary Whinnett
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
18HH4722, internal ref number
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
Patients at risk of developing life-threatening heart rhythm disorders undergo insertion of Implantable Cardioverter-Defibrillators (ICDs). ICDs are specialised pacemakers designed to treat these rhythm disorders by delivering an electrical shock or rapid stimulation to the heart to restore a normal, healthy rhythm.
Although these devices save lives when treating dangerous rhythms, they have some important problems. ICDs sometimes mistakenly treat normal rhythms or rhythm disorders that are not life-threatening. These treatments can be dangerous for the patient either by shocks damaging the heart or by rapid stimulation triggering a more dangerous rhythm disorder.
In our study, we plan to improve the scientific understanding of what makes a rhythm disorder dangerous and to develop a blood flow sensor, that could be built into an ICD, that can help ICDs treat only dangerous rhythm disorders.
We will invite patients to take part in our study if they already have an ICD and are attending the ICD clinic or if they are undergoing a procedure to replace their ICD battery, treat a rhythm disorder or check their heart arteries for narrowing as well as patients having an ICD inserted.
We will change the settings of their pacemaker to temporarily produce fast heart rates, similar to heart rhythm disorders, while recording the blood flow using the sensor and measuring blood pressure and blood supply to the brain and heart. We will also ask some patients to exercise on a treadmill and to lie on a specialised table that can recreate different postures such as standing up and lying down. This is because posture affects how dangerous a rhythm disorder is for a patient and heart rhythms during exercise are sometimes mistaken for dangerous rhythms.
This will allow us to determine what blood flow level, measured by the sensor, corresponds to a dangerous rhythm.
REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/1998
Date of REC Opinion
18 Jan 2019
REC opinion
Further Information Favourable Opinion