Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in prediction of response to CRT. The hypothesis is that the presence of mechanical dyssynchrony (measured using TDI echocardiography) successfully identifies heart failure patients who will respond to CRT. Conversely, the absence of mechanical dyssynchrony is associated with a low/no response to CRT. This is a three arm study. Group 1 comprises patients with dyssynchrony on TDI who are implanted with a biventricular ICD whereas Group 2 patients comprise patients who have no dyssynchrony. Group 2 patients are randomised 1:1 to either receive a biventricular ICD (2a) or an ICD (2b). All patients undergo a NYHA class assessment, a cardiopulmonary exercise test, and an echocardiogram at baseline and at 6 months follow up. Baseline and 6 months findings will be compared in all three groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Biventricular ICD
Implantable Defibrillator
Barts and the London NHS Trust
London, United Kingdom
Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months
Time frame: 6 months
Change in New York Heart Association (NYHA) class from baseline to 6 months
Time frame: 6 months
Change in Quality-of-Life score from baseline to 6 months
Time frame: 6 months
Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR
Time frame: 6 months
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