NCT03992560 A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
| NCT ID | NCT03992560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 218 participants |
| Start Date | 2019-07-05 |
| Primary Completion | 2024-07-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 218 participants in total. It began in 2019-07-05 with a primary completion date of 2024-07-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT03992560 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03992560 currently recruiting?
Yes, NCT03992560 is actively recruiting participants. Visit ClinicalTrials.gov or contact Guy's and St Thomas' NHS Foundation Trust to inquire about joining.
Where is the NCT03992560 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT03992560 clinical trial?
NCT03992560 is sponsored by Guy's and St Thomas' NHS Foundation Trust. The trial plans to enroll 218 participants.