The research aims to compare the response of Cardiac Resynchronisation Therapy (CRT) using HF ECG guided or the conventional method of Q-LV measurement guided optimisation for left ventricular, pacing site.
The study aims to demonstrate that left ventricular (LV) pacing site optimisation using high frequency (HF) ECG improves LV reverse remodeling response to Cardiac Resynchronization Therapy (CRT), compared with Q-LV (Q-wave on the surface ECG to LV Electrogram) measurement after 6 months of treatment. Participants will be implanted with a Cardiac Resynchronisation Therapy device with either pacemaker or defibrillator function. The study is a single-Centre, randomized, prospective trial. One hundred and eighty participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization. The participants will be followed up for a period of 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
A high frequency ECG map will be performed to assess the optimum left ventricular pacing site.
Measurement of Q wave on 12 lead ECG to LV stimulus to assess optimum left ventricular pacing site.
University Hospitals Birmingham
Birmingham, West Midlands, United Kingdom
RECRUITINGLeft Ventricular Reverse Remodelling
Absolute difference in left ventricular end systolic volume greater than or equal to 10%
Time frame: 6 months
Change in NYHA Class
NYHA Class Assessment
Time frame: 6 months
Change in quality of life score
Assessment through Minnesota Living with Heart Failure Questionnaire
Time frame: 6 months
Change in left ventricular ejection fraction
Improved left ventricular ejection fraction
Time frame: 6 months
Reduction in QRS duration
QRS duration measured on 12 lead ECG
Time frame: 6 months
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