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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Device: Guide CRT Software Prototype

• Registration Number: NCT03992560
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Study Start: 2019-07-05
• Status Verified: 2022-08
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10
• Primary Completion: 2024-07-05
• Study Completion: 2026-07-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI guided CRT implantation	Guide CRT Software Prototype	-

Primary Outcome Measures

Name	Time	Method
>15% reduction in end systolic volume	6 months	\>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant

Secondary Outcome Measures

Name	Time	Method
>10% reduction in end diastolic volume	6 months	\>10% reduction in end diastolic volume as derived from 2D echocardiogram
5% absolute increase in left ventricular ejection fraction	6 months	5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram

Trial Locations

Locations (1)

Guys and St Thomas NHS Foundation Trust; 🇬🇧 London, United Kingdom