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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
The left ventricular endocardial lead will be passed through the intra-atrial septum
Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom
RECRUITINGCardiopulmonary Exercise Test
Improvement in peak oxygen consumption
Time frame: 3 months
New NYHA Class
Change in New York Heart Association functional Class
Time frame: 3 months
6 minute walk
Change in 6 minute hall walk test distance
Time frame: 3 months
Quality of life
Minnesota Living with heart failure questionnaire score
Time frame: 3 months
Echocardiography
Change in size and function of the heart
Time frame: 3 months
Digital photoplethysmography
Cardiac output
Time frame: 3 months
Biochemical response
Change in eGFR (estimated glomerular filtration rate) and NT pro BNP (N terminal pro brain natriuretic peptide) levels.
Time frame: 3 months
Composite cardiac assessment score
Change in composite assessment score made up of symptom, exercise tolerance, echocardiographic and biochemical parameters.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.