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

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · Jun 19, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help patients with heart problems caused by reduced blood flow, known as ischemic cardiomyopathy. Specifically, the study compares a method that uses advanced MRI technology to guide the implantation of a cardiac resynchronization therapy (CRT) device against the traditional method of implantation. The goal is to see if the MRI-guided approach leads to better heart function after six months. Participants will have their heart function checked at various points: when they join the study, after the device is implanted, before leaving the hospital, and again at six weeks and six months later.

To be eligible for this trial, participants need to be at least 18 years old and have a heart condition that meets specific guidelines for CRT treatment. They should also have been on stable heart medications for at least three months. The study welcomes patients with atrial fibrillation, which is a type of irregular heartbeat. However, there are some exclusions, such as those with certain health conditions that would prevent the safe use of the device or MRI. If eligible, participants can expect a supportive environment with regular check-ins to monitor their progress over the six-month study period.

Gender

ALL

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