Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - \>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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

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

Locations (1)

Guys and St Thomas NHS Foundation Trust
London, United Kingdom