Cardiac Magnetic Resonance Imaging Guided Left Ventricular Lead Placement

NCT01417624 | Unknown Phase 3 DMC

• 1 other identifier: RBH2011HS008B
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure is a common, costly, disabling and potentially lethal condition. Despite well recognised and proven drug therapies, many patients remain breathless on exertion. A special pacemaker (cardiac resynchronisation therapy) may help improve symptoms of breathlessness and survival by restoring coordinated beating of the heart. However, despite careful planning and the knowledge of the most appropriate selection criteria, up to a third of patients do not get the desired beneficial effects after the pacemaker has been implanted. The implantation of the special pacemaker requires three leads (wires) to be inserted within the heart. Currently this is undertaken under X-ray guidance. Some patients may have scarring of the heart muscle due to previous heart attacks or their underlying condition. The X-ray technique cannot see this and therefore the doctor may implant the lead in such an area of scar tissue. Cardiac magnetic resonance imaging (CMR) can demonstrate these areas of scar. The study aims to investigate whether CMR can better predict where the wires should be placed. The CMR pictures will be taken before the patient has the special pacemaker implanted.

Conditions

Heart Failure

Keywords

Heart Failure; Cardiac Resynchronisation Therapy

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test Distance

  CMR guided LV lead placement during CRT implantation results in improved exercise tolerance at 12 months in patients with heart failure.

  12 months

Secondary Outcomes (7)

• Exercise Tolerance (MVO2)

  6, 12 months following CRT Implantation

• Blood Tests - Serum BNP

  1, 6, 12 months following CRT Implantation

• Clinical -NYHA Classification

  1, 6, 12 months following CRT

• Quality of Life Questionnaires

  1,6,12 months following CRT Implantation

• Echocardiography

  1,6,12 months following CRT Implantation

Study Arms (2)

Control Group - Standard

PLACEBO COMPARATOR

This will be a randomised controlled unblinded prospective study recruiting patients in sinus rhythm with LBBB (QRS width ≥ 120ms) and a LV ejection fraction of below 35% who meet the current guidelines for CRT implantation. Patients will be randomised to one of two groups (1:1 randomisation) Conventional LV lead placement - the LV lead will be placed according to standard techniques without knowledge of the patient's CMR findings

Other: CMR Guidance in terms of guiding LV lead implantation

Active CMR guided Arm

ACTIVE COMPARATOR

This will be a randomised controlled unblinded prospective study recruiting patients in sinus rhythm with LBBB (QRS width ≥ 120ms) and a LV ejection fraction of below 35% who meet the current guidelines for CRT implantation.Patients will be randomised to one of two groups (1:1 randomisation): CMR guided LV lead placement - an expert panel will decide pre-operatively the optimal branch of the coronary sinus for LV lead placement based on the presence of myocardial scar tissue and coronary sinus anatomy. The operator will informed as to the optimal vein to target for delivery of the LV lead. Should this be technically unfeasible (e.g. due to pacing considerations or stability of LV lead position), then the most suitable vein will be used at the time of implantation.

Other: CMR Guidance in terms of guiding LV lead implantation

Interventions

CMR Guidance in terms of guiding LV lead implantation OTHER

Following randomisation, the optimal position of the LV lead will be determined either according to current standard criteria (as proposed by the primary operator) or with CMR guidance. The CRT device will be implanted using established conventional techniques. The CMR study will be performed pre-implantation only. The distribution of myocardial scar and fibrosis will be derived from this study. A CMR venogram will also be generated and the suggested optimal venous tributaries of the great cardiac vein will be identified from discussion between the principal investigator and senior CMR physician. This information will be used for those in the active arm only.

Also known as: A cardiac Magnetic resonance Scan using Gadolinium Contrast

Active CMR guided Arm; Control Group - Standard

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give written informed consent
• Age \>18 years old
• Successful CRT implantation (with or without a defibrillator)
• NYHA Class III-IV Heart Failure (or NYHA II with NYHA III/IV symptoms in the preceding 12 months)
• LVEF \<35% (Calculated using echocardiography or Cardiac MR) at the time of implantation
• QRS duration \> 120ms with Left Bundle Branch Block morphology on ECG
• Sinus Rhythm
• Optimal Tolerated Medical Therapy for Heart Failure

You may not qualify if:

• Severe, life threatening non cardiac disease
• Active malignant disease and recent (\<5 years) malignant disease
• Prior Heart Transplant
• Recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrollment into the study
• Pregnancy
• Failure to participate in consent process
• Atrial Fibrillation
• Conventional pacemaker in situ
• Heart Failure requiring constant intravenous therapy including diuretics and/or inotropes
• Recent revascularisation procedure i.e. coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the last three months
• Contraindications to a CMR study

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, London, SW3 6NP, United Kingdom

RECRUITING

Related Links

• Homepage for Royal Brompton \& Harefield NHS Foundation Trust

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rakesh Sharma, MRCP PhD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rakesh Sharma, MRCP PhD

CONTACT

00 44 207 352 8121; rakesh.sharma@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: August 16, 2011

Record last verified: 2011-08

Locations

GB (1)