RecruitingNot ApplicableNCT03992560

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

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrollment

218 participants

Start Date

Jul 5, 2019

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria5

>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 Criteria8

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

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Interventions

DEVICEGuide 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