Actively Recruiting
A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2023-03-10
218
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
G
Guy's and St Thomas' NHS Foundation Trust
Lead Sponsor
K
King's College London
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Standard indication for CRT-P or CRT-D according to European Society of Cardiology (ESC)/European Heart Rhythm Association (EHRA) guidelines
- Stable on optimal medical therapy for at least 3 months
- Ischemic heart disease cause
- Patients with atrial fibrillation can be included
You will not qualify if you...
- Contraindication to pacemaker or implantable cardioverter-defibrillator (ICD) implantation
- Need for endocardial pacing
- Contraindication to gadolinium contrast enhanced cardiac MRI scan
- Significant claustrophobia
- Significant kidney impairment with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2
- Existing pacemaker or ICD system or CRT system extraction within last 6 months
- Participation in other studies with active treatment or investigational arm
- Pregnant or planning pregnancy within next 7 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guys and St Thomas NHS Foundation Trust
London, United Kingdom, SE1 7EH
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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