Heart Failure
Conditions
Keywords
Heart Failure, Cardiac Resynchronisation Therapy, Transseptal left ventricular endocardial lead
Brief summary
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.
Interventions
DEVICETargeted left ventricular endocardial lead placement
The left ventricular endocardial lead will be passed through the intra-atrial septum
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years * NYHA class II-IV * LVEF ≤35% * QRS ≥120 milliseconds * Optimal tolerated medical therapy * Either unable to position an LV lead via the standard coronary sinus on CRT implantation * OR Recipient of a CRT-P or CRT-D system for greater than 6 months for standard indications AND limited improvement or worsened clinical status despite device optimisation * Informed consent
Exclusion criteria
* Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders * Previous atrial septal defect device closure. * Chronic renal dialysis and End stage liver disease * History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months * Presence of correctable valvular disease (aortic/mitral) * Mitral valve prosthesis. * Contra indication to vitamin K antagonist * Unresolved intra-cardiac thrombus * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary Exercise Test | 3 months | Improvement in peak oxygen consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 3 months | Minnesota Living with heart failure questionnaire score |
| Digital photoplethysmography | 3 months | Cardiac output |
| Biochemical response | 3 months | Change in eGFR (estimated glomerular filtration rate) and NT pro BNP (N terminal pro brain natriuretic peptide) levels. |
| Composite cardiac assessment score | 3 months | Change in composite assessment score made up of symptom, exercise tolerance, echocardiographic and biochemical parameters. |
| New NYHA Class | 3 months | Change in New York Heart Association functional Class |
| 6 minute walk | 3 months | Change in 6 minute hall walk test distance |
| Echocardiography | 3 months | Change in size and function of the heart |
Other
| Measure | Time frame | Description |
|---|---|---|
| Targeting success | Intra operative | Success at targeting the site which produces the greatest haemodynamic response using echocardiogaphic speckle tracking, endocardial electrical mapping and myocardial perfusion scintigraphy. |
| Freedom from adverse events | 1 year | Acute: Tamponade, effusion, systemic thromboembolism; acute lead displacement and arrhythmia Chronic: systemic thromboembolism; lead displacement, disfunction or fracture; device related systemic infection; bleeding; arrhythmia |
| Medium term clinical outcomes | 6 months | Assess medium term response to treatment with regards to symptoms, exercise tolerance, echocardiographic and biochemical parameters (as specified above), particularly systemic thrombosis. |
Countries
United Kingdom
Contacts
Primary ContactCharles Butcher, MBBS MRCP
Outcome results
None listed