LV Endocardial Cardiac Resynchronisation Therapy
- Conditions
- Heart Failure
- Interventions
- Device: Targeted left ventricular endocardial lead placement
- Registration Number
- NCT02174289
- Lead Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description No Biventricular pacing Targeted left ventricular endocardial lead placement - Active Bi-ventricular Pacing Targeted left ventricular endocardial lead placement -
- Primary Outcome Measures
Name Time Method Cardiopulmonary Exercise Test 3 months Improvement in peak oxygen consumption
- Secondary Outcome Measures
Name Time Method Quality of life 3 months Minnesota Living with heart failure questionnaire score
Echocardiography 3 months Change in size and function of the heart
Biochemical response 3 months Change in eGFR (estimated glomerular filtration rate) and NT pro BNP (N terminal pro brain natriuretic peptide) levels.
Digital photoplethysmography 3 months Cardiac output
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
Composite cardiac assessment score 3 months Change in composite assessment score made up of symptom, exercise tolerance, echocardiographic and biochemical parameters.
Trial Locations
- Locations (1)
Royal Brompton and Harefield NHS Foundation Trust
🇬🇧London, United Kingdom