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

NCT03992560 | Recruiting DMC

• 1 other identifier: 1.1
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• >15% reduction in end systolic volume

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

  6 months

Secondary Outcomes (2)

• 5% absolute increase in left ventricular ejection fraction

  6 months

• >10% reduction in end diastolic volume

  6 months

Study Arms (2)

Standard CRT implantation

NO INTERVENTION

MRI guided CRT implantation

EXPERIMENTAL

Device: Guide CRT Software Prototype

Interventions

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. We are able to use the MRI information to assess the best location to place the left ventricular lead for a CRT device and then superimpose this location onto the real-time X-Ray fluoroscopic images during the left ventricular lead implantation

MRI guided CRT implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guys and St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: July 5, 2019
• Primary Completion: July 5, 2024
• Study Completion (Estimated): July 5, 2026
• Last Updated: March 10, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)