LV Endocardial Cardiac Resynchronisation Therapy (ENDO-CRT)

Royal Brompton & Harefield NHS Foundation Trust

Status: Unknown

Conditions: Heart Failure

Treatments: Device: Targeted left ventricular endocardial lead placement

Study type: Interventional

Funder types: Other

Identifiers

NCT02174289

ISROTH20092 (Other Grant/Funding Number)

2013PS003H

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Active Bi-ventricular Pacing

Active Comparator group

Treatment:

Device: Targeted left ventricular endocardial lead placement

No Biventricular pacing

Placebo Comparator group

Treatment:

Device: Targeted left ventricular endocardial lead placement