None listed
Conditions
Brief summary
The aim is to determine whether sequential optimization of cardiac resynchronization therapy (CRT) can improve outcome in advanced chronic heart failure (CHF). The efficacy of this strategy will be established by assessment of functional capacity using measurement of 6-minute walk test distance (6MWT), B-type natriuretic peptide (BNP), echocardiographic measures and quality of life (QoL, based on a disease specific questionnaire: Minnesota Living with Heart Failure questionnaire, MLHFQ, and the multi-attribute utility indices: EQ-5D and Assessment of Quality of Life (AQoL). The cost- effectiveness of the strategy will also be assessed, relative to non-optimization. The hypotheses are that optimization of atrioventricular delay (AVD) setting will lead to (1) improved exercise capacity (2) improved BNP, LV structure and QoL over the ensuing 6 months, and be (3) cost-effective.
Interventions
Randomized, double-blind, cross-over trial to evaluate the utility of echocardiographic optimization of the AV delay in symptomatic (Functional Class [FC] III) CHF patients who have had CRT implanted.
Optimization is a process undertaken by a pacing technician during echo. Those who are randomized to the optimization group (known only to the study Nurse and the technician) will have their CRT device 'optimized ' by radio frequency. This procedure can take between 15 and 30 minutes and alters the
Randomized, double-blind, cross-over trial to evaluate the utility of echocardiographic optimization of the AV delay in symptomatic (Functional Class [FC] III) CHF patients who have had CRT implanted. Optimization is a process undertaken by a pacing technician during echo. Those who are randomized to the optimization group (known only to the study Nurse and the technician) will have their CRT device 'optimized ' by radio frequency. This procedure can take between 15 and 30 minutes and alters the amount of electrical current delivered to the pacing wires of the device in order to produce "optimal' pumping by the heart chambers. It is non-invasive and the procedure is not a new technique. It is not universally used though as its efficacy in producing improved outcomes has yet to be determined.
Sponsors
The Baker IDI
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of implanted CRT device * Device optimization performed at time of implant [e.g. QuickOpt for St Jude etc.] * In sinus rhythm * Able to perform a 6-minute walk test * No more than moderate valvular heart disease
Exclusion criteria
* Life expectancy <1 year * In atrial fibrillation * Prosthetic mitral valve replacement.
Outcome results
None listed