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LV Endocardial Cardiac Resynchronisation Therapy (ENDO-CRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174289
Recruitment Status : Unknown
Verified June 2014 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : June 25, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Heart Failure Device: Targeted left ventricular endocardial lead placement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2014
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Active Bi-ventricular Pacing Device: Targeted left ventricular endocardial lead placement
The left ventricular endocardial lead will be passed through the intra-atrial septum

Placebo Comparator: No Biventricular pacing Device: Targeted left ventricular endocardial lead placement
The left ventricular endocardial lead will be passed through the intra-atrial septum




Primary Outcome Measures :
  1. Cardiopulmonary Exercise Test [ Time Frame: 3 months ]
    Improvement in peak oxygen consumption


Secondary Outcome Measures :
  1. New NYHA Class [ Time Frame: 3 months ]
    Change in New York Heart Association functional Class

  2. 6 minute walk [ Time Frame: 3 months ]
    Change in 6 minute hall walk test distance

  3. Quality of life [ Time Frame: 3 months ]
    Minnesota Living with heart failure questionnaire score

  4. Echocardiography [ Time Frame: 3 months ]
    Change in size and function of the heart

  5. Digital photoplethysmography [ Time Frame: 3 months ]
    Cardiac output

  6. Biochemical response [ Time Frame: 3 months ]
    Change in eGFR (estimated glomerular filtration rate) and NT pro BNP (N terminal pro brain natriuretic peptide) levels.

  7. Composite cardiac assessment score [ Time Frame: 3 months ]
    Change in composite assessment score made up of symptom, exercise tolerance, echocardiographic and biochemical parameters.


Other Outcome Measures:
  1. Freedom from adverse events [ Time Frame: 1 year ]

    Acute: Tamponade, effusion, systemic thromboembolism; acute lead displacement and arrhythmia

    Chronic: systemic thromboembolism; lead displacement, disfunction or fracture; device related systemic infection; bleeding; arrhythmia


  2. Medium term clinical outcomes [ Time Frame: 6 months ]
    Assess medium term response to treatment with regards to symptoms, exercise tolerance, echocardiographic and biochemical parameters (as specified above), particularly systemic thrombosis.

  3. Targeting success [ Time Frame: Intra operative ]
    Success at targeting the site which produces the greatest haemodynamic response using echocardiogaphic speckle tracking, endocardial electrical mapping and myocardial perfusion scintigraphy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174289


Contacts
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Contact: Charles Butcher, MBBS MRCP c.butcher@rbht.nhs.uk

Locations
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United Kingdom
Royal Brompton and Harefield NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Charles Butcher, MBBS MRCP       c.butcher@rbht.nhs.uk   
Principal Investigator: Tom Wong         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Principal Investigator: Tom Wong, MD FESC Royal Brompton and Harefield NHS Foundation Trust
Publications:

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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02174289    
Other Study ID Numbers: 2013PS003H
ISROTH20092 ( Other Grant/Funding Number: Boston Scientific Global ISR program )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: June 2014
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Heart Failure
Cardiac Resynchronisation Therapy
Transseptal left ventricular endocardial lead
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases