A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy

Study Overview
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Brief Summary
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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).

Official Title
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A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: Guide CRT Software Prototype


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard CRT implantation<br> | |
| Experimental: MRI guided CRT implantation<br> | Device: Guide CRT Software Prototype<br>* The medical device in the trial is a software programme that allows image fusion of previously acquired MRI images with real-time X-Ray fluoroscopic images in the cardiac catheter laboratory. We are able to use the MRI information to assess the best location to place the left ventricular lead for a CRT device and then superimpose this location onto the real-time X-Ray fluoroscopic images during the left ventricular lead implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| >15% reduction in end systolic volume | >15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5% absolute increase in left ventricular ejection fraction | 5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram | 6 months | 
| >10% reduction in end diastolic volume | >10% reduction in end diastolic volume as derived from 2D echocardiogram | 6 months |