Heart Failure Clinical Trial
Official title:
A Randomised Double-blinded Cross Over Study to Evaluate the Improvement of Left Ventricular Systolic Failure Using Targeted Left Ventricular Endocardial Lead Placement in Cardiac Resynchronisation Therapy.
Cardiac resynchronisation therapy (CRT) is an established treatment for severe systolic
heart failure with well documented benefits in symptom improvement and reduction of
morbidity and mortality. However, upto 30% of patients do not respond to treatment despite
fulfilling the recommended indications. Lack of clinical response may be the result of
imperfect left ventricular lead placement in the veins around the heart with conventional
techniques. Optimum lead placement may constrained by coronary venous anatomy and may
overlie scarred heart muscle or may not be at the site of latest electrical depolarisation.
In a further 10% of patients, conventional left ventricular lead placement is not possible
for other technical reasons.
Left ventricular endocardial lead placement may overcome the limitations and allow placement
to be guided by echocardiography, electrical mapping and the pattern of heart muscle
scarring.
We aim to investigate if targeted left ventricular endocardial lead placement improves
exercise capacity, heart failure symptoms, heart function and size, heart pumping efficiency
and biochemical markers of heart strain. Each parameter will be assessed independently and
as part of a composite cardiac performance score.
Patients with heart failure will be enrolled who require an endocardial left ventricular
lead on clinical grounds as either conventional left ventricular lead implantation has
technically failed or they have clinically non-responded to CRT.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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