Pragmatic versus electrocardiographic-guided loop recorder position
Research type
Research Study
Full title
Pragmatic versus electrocardiographic-guided loop recorder position – an outcomes study
IRAS ID
178021
Contact name
Dahlia Abdul-Rahman
Contact email
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
We want to find out whether the position of a loop recorder determines the sensed ECG and or outcomes data.
Loop recorders are small insertable devices that can monitor the heart rhythm for up to 3 years. They are usually positioned on the front of the chest during a short procedure performed under local anaesthetic. It is unclear whether the position of the device influences its utility. Current practice is dictated by physician preference. Two major positions are chosen: below the clavicle and at the mid chest level to the left of the sternum.
A higher position is anecdotally associated with less scarring and is more comfortable, particularly in women in whom the lower position means that the device is located between (or in) the breasts. Furthermore, in the event that the loop recorder identifies an indication for pacemaker implantation (up to 30%) a high position allows implantation of the pacemaker and device removal through the same incision.
We want to find out if there is a clinical disadvantage from the higher infraclavicular position.
We will collect data retrospectively on all loop recorder implants in 2010 to examine outcomes and management changes as a result of the loop recorder split by implant position. We will also perform a prospective audit collection of ECG traces obtained at implant to determine whether the position influences ECG appearance.
Both work streams will be an observational using routinely collected data. Patients are allocated in a random fashion to lists of operators with different approaches.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0541
Date of REC Opinion
21 Mar 2015
REC opinion
Favourable Opinion