Identifying pacemaker patients who may benefit from a device upgrade.
Research type
Research Study
Full title
Identifying pacemaker patients who may be eligible for a device upgrade as a result of the NICE TA314 guidance.
IRAS ID
200604
Contact name
Keith Pearce
Contact email
Sponsor organisation
University Hospital of South Manchester NHS Foundation Trust
Duration of Study in the UK
0 years, 9 months, 5 days
Research summary
The proposed research study will identify the percentage of bradycardia device patients who fit the published NICE TA314 eligibility criteria for an upgrade to a newer pacemaker device known as cardiac resynchronisation therapy (CRT).
The study involves analysing anonymised data collected from routine visits to the North West Heart Centre (NWHC) during which patients will undergo a routine pacemaker check, symptom assessment, a resting 12-lead electrocardiogram (ECG) and an echocardiogram. All tests are a normal part of routine clinical care.
The pacemaker check will determine the percentage of right ventricular (RV) apical pacing. Patients will then be assessed to determine whether they fit the NICE TA314 upgrade criteria by i) undergoing a resting 12-lead ECG to assess QRS duration and the presence of left bundle branch block (LBBB), ii) assessment of symptoms which may be compatible with heart failure (HF) and iii) identifying impairment of left ventricular ejection fraction (LVEF) and cardiac function on echocardiography.
Patients who meet at least one of the following three criteria (they report symptoms which may be compatible with HF, LBBB is identified on the ECG and/or they are RV paced ≥ 40% of the time) will be divided into one of three groups depending on whether they meet one, two or all of the three criteria required for inclusion in the study. If clinically indicated (e.g. the patient has developed LBBB or they have HF symptoms), an echocardiogram will be arranged as part of routine clinical practice.
A device upgrade is recommended in patients with impaired cardiac function and an associated LVEF of 35% or less, who are experiencing HF symptoms. The patient's New York Heart Association (NYHA) class of symptoms and specific ECG parameters (e.g. QRS duration and presence of left bundle branch block) influence the type of device recommended under the NICE TA314 guidance.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
16/ES/0091
Date of REC Opinion
13 Jul 2016
REC opinion
Further Information Favourable Opinion