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

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).

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: Guide CRT Software Prototype

• Study Type: Interventional
• Enrollment (Anticipated): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guys and St Thomas NHS Foundation Trust
    • Contact: Humra Chadwick; Phone Number: 56217 02071887188; Email: humra.chadwick1@gstt.nhs.uk
    • Principal Investigator: Aldo Rinaldi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard CRT implantation
Experimental: MRI guided CRT implantation	Device: Guide CRT Software Prototype; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
>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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
5% absolute increase in left ventricular ejection fraction	5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram	6 months
>10% reduction in end diastolic volume	>10% reduction in end diastolic volume as derived from 2D echocardiogram	6 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Anticipated): July 5, 2024
• Study Completion (Anticipated): July 5, 2026

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No