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Each trial has specific eligibility criteria including age, condition, medical history, and current treatments. TrialConnect shows you trials that may match your situation, but only the trial team can confirm eligibility.

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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Guide CRT Software Prototype (device)
How long the study runs: Study runs about 84 months (dates as stated)
About the drug or intervention: Guide CRT Software Prototype — device: 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.
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 218
Started: 2019-07-05
Last checked: 2022-08

Plain English Summary

What is this study?

• Testing a new treatment for cardiovascular diseases
• NA - 218 participants
• 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

Who can take part?

• Ages 18 Years and over
• Diagnosed with cardiovascular diseases

Where?

• London - Guys and St Thomas NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

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).

Cardiovascular Diseases

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

✓\>18yrs of age
✓Standard indication for CRT-P or CRT-D according to European Society of Cardiology (ESC)/European Heart Rhythm...
✓Stable on optimal medical therapy for at least 3 months
✓Ischaemic aetiology
✓Patients with atrial fibrillation can be included

Who cannot take part

✗Any safety concern to pacing /implantable cardioverter-defibrillator (ICD) implant
✗Requirement for endocardial pacing
✗safety concern to gadolinium contrast enhanced heart Magnetic Resonance (MR) scanning
✗Significant claustrophobia
✗Significant kidney impairment with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2

See the full 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 Is This Study? (1 UK site)

Guys and St Thomas NHS Foundation Trust

London SE1 7EH, United Kingdom

Recruiting

Site contact (verified)

Aldo RinaldiPrincipal Investigator

Humra Chadwick02071887188 humra.chadwick1@gstt.nhs.uk

Data sourced from ClinicalTrials.gov · Last verified: 2022-08