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Clinical Trials/NCT02174289
NCT02174289
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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.

Royal Brompton & Harefield NHS Foundation Trust1 site in 1 country32 target enrollmentApril 2014
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Enrollment
32
Locations
1
Primary Endpoint
Cardiopulmonary Exercise Test
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
April 2017
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Cardiopulmonary Exercise Test

Time Frame: 3 months

Improvement in peak oxygen consumption

Secondary Outcomes

  • Digital photoplethysmography(3 months)
  • New NYHA Class(3 months)
  • 6 minute walk(3 months)
  • Quality of life(3 months)
  • Echocardiography(3 months)
  • Biochemical response(3 months)
  • Composite cardiac assessment score(3 months)

Study Sites (1)

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