Comparing MRI guided CRT implantation to standard CRT for heart disease patients
A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
This study is testing if using MRI to help place a heart device works better than the usual method for patients with heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT03992560 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of MRI guided cardiac resynchronization therapy (CRT) implantation compared to conventional CRT implantation in patients with ischaemic cardiomyopathy. Participants will be monitored at various intervals including enrolment, implant, pre-discharge, and at 6 weeks and 6 months post-implantation. The primary outcome will be assessed by measuring the change in end systolic volume using echocardiography at the 6-month mark. The study will utilize a software prototype developed by Siemens to guide the CRT procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with ischaemic cardiomyopathy who are stable on optimal medical therapy and meet the criteria for CRT implantation.
Not a fit: Patients with contraindications to pacing devices, significant renal impairment, or those currently participating in other investigational studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could lead to improved CRT response rates in patients with ischaemic cardiomyopathy.
How similar studies have performed: While there is ongoing research in the field of CRT, the use of MRI guidance in this specific context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- Guys and St Thomas NHS Foundation Trust — London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.