LV Endocardial Cardiac Resynchronisation Therapy (ENDO-CRT)

June 26, 2014 updated by: Royal Brompton & Harefield NHS Foundation Trust

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Royal Brompton and Harefield NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Tom Wong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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.
6 months
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.
Intra operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Investigators

  • Principal Investigator: Tom Wong, MD FESC, Royal Brompton and Harefield NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 26, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013PS003H
  • ISROTH20092 (Other Grant/Funding Number: Boston Scientific Global ISR program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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