Status:
UNKNOWN
Cardiac Magnetic Resonance Imaging Guided Left Ventricular Lead Placement
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 (card...
Detailed Description
Cardiac Resynchronisation Therapy (CRT) is currently recommended for patients with heart failure who have symptomatic left ventricular (LV) systolic impairment and a prolonged QRS duration.1, 2 Up to ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01417624
Start Date
August 1 2011
End Date
June 1 2013
Last Update
August 16 2011
Active Locations (1)
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1
Royal Brompton Hospital
London, London, United Kingdom, SW3 6NP