NCT03992560
Recruiting
Not Applicable
A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
ConditionsCardiovascular Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Enrollment
- 218
- Locations
- 1
- Primary Endpoint
- >15% reduction in end systolic volume
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of the study is to determine whether MRI guided CRT implantation (using Siemen's software prototype) is superior to standard treatment in terms of CRT response. Data will be collected at enrolment, implant, pre-discharge, 6 weeks and 6 months. The total duration of the investigation will be 6 months.
The primary endpoint will be assessed by calculating the difference in the proportion of responders (>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant).
Investigators
Eligibility Criteria
Inclusion Criteria
- •\>18yrs of age
- •Standard indication for CRT-P or CRT-D according to European Society of Cardiology (ESC)/European Heart Rhythm (EHRA) guidelines.1
- •Stable on optimal medical therapy for at least 3 months
- •Ischaemic aetiology
- •Patients with atrial fibrillation can be included
Exclusion Criteria
- •Any contraindication to pacing /implantable cardioverter-defibrillator (ICD) implant
- •Requirement for endocardial pacing
- •Contraindication to gadolinium contrast enhanced cardiac Magnetic Resonance (MR) scanning
- •Significant claustrophobia
- •Significant renal impairment with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
- •Existing pacemaker or ICD system or extraction of a CRT system within the last 6 months
- •Participation in other studies with active treatment/ investigational arm
- •Pregnant or planning to become pregnant in the next 7 months
Outcomes
Primary Outcomes
>15% reduction in end systolic volume
Time Frame: 6 months
\>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant
Secondary Outcomes
- >10% reduction in end diastolic volume(6 months)
- 5% absolute increase in left ventricular ejection fraction(6 months)
Study Sites (1)
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