Clinical trial NCT02174289: LV Endocardial Cardiac Resynchronisation Therapy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Cardiac Resynchronisation Therapy
Transseptal left ventricular endocardial lead
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiopulmonary Exercise Test
timeFrame: 3 months
Secondary outcomes:
measure: New NYHA Class
timeFrame: 3 months
measure: 6 minute walk
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Echocardiography
timeFrame: 3 months
measure: Digital photoplethysmography
timeFrame: 3 months
measure: Biochemical response
timeFrame: 3 months
measure: Composite cardiac assessment score
timeFrame: 3 months
Other outcomes:
measure: Freedom from adverse events
timeFrame: 1 year
measure: Medium term clinical outcomes
timeFrame: 6 months
measure: Targeting success
timeFrame: Intra operative
Locations:
city: London
country: United Kingdom
facility: Royal Brompton and Harefield NHS Foundation Trust
Study officials:
affiliation: Royal Brompton and Harefield NHS Foundation Trust
name: Tom Wong, MD FESC
role: PRINCIPAL_INVESTIGATOR
References:
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