A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
NCT ID: NCT03992560
Last Updated: 2023-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
218 participants
INTERVENTIONAL
2019-07-05
2026-07-05
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard CRT implantation
No interventions assigned to this group
MRI guided CRT implantation
Guide CRT Software Prototype
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
Interventions
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Guide CRT Software Prototype
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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King's College London
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Guys and St Thomas NHS Foundation Trust
London, , United Kingdom
Countries
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Facility Contacts
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Other Identifiers
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1.1
Identifier Type: -
Identifier Source: org_study_id
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