LV Endocardial Cardiac Resynchronisation Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Targeted left ventricular endocardial lead placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Bi-ventricular Pacing<br> | Device: Targeted left ventricular endocardial lead placement<br>* The left ventricular endocardial lead will be passed through the intra-atrial septum<br>|
| Placebo Comparator: No Biventricular pacing<br> | Device: Targeted left ventricular endocardial lead placement<br>* The left ventricular endocardial lead will be passed through the intra-atrial septum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary Exercise Test | Improvement in peak oxygen consumption | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New NYHA Class | Change in New York Heart Association functional Class | 3 months | 
| 6 minute walk | Change in 6 minute hall walk test distance | 3 months | 
| Quality of life | Minnesota Living with heart failure questionnaire score | 3 months | 
| Echocardiography | Change in size and function of the heart | 3 months | 
| Digital photoplethysmography | Cardiac output | 3 months | 
| Biochemical response | Change in eGFR (estimated glomerular filtration rate) and NT pro BNP (N terminal pro brain natriuretic peptide) levels. | 3 months | 
| Composite cardiac assessment score | Change in composite assessment score made up of symptom, exercise tolerance, echocardiographic and biochemical parameters. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Cardiac Resynchronisation Therapy, Transseptal left ventricular endocardial lead