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

Primary Purpose

Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Guide CRT Software Prototype
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guys and St Thomas NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard CRT implantation

MRI guided CRT implantation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

5% absolute increase in left ventricular ejection fraction
5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram
>10% reduction in end diastolic volume
>10% reduction in end diastolic volume as derived from 2D echocardiogram

Full Information

First Posted
June 18, 2019
Last Updated
March 9, 2023
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT03992560
Brief Title
A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
Acronym
TACTIC CRT
Official Title
A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
July 5, 2024 (Anticipated)
Study Completion Date
July 5, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard CRT implantation
Arm Type
No Intervention
Arm Title
MRI guided CRT implantation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Guide CRT Software Prototype
Intervention Description
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
Primary Outcome Measure Information:
Title
>15% reduction in end systolic volume
Description
>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant
Time Frame
6 months
Secondary Outcome Measure Information:
Title
5% absolute increase in left ventricular ejection fraction
Description
5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram
Time Frame
6 months
Title
>10% reduction in end diastolic volume
Description
>10% reduction in end diastolic volume as derived from 2D echocardiogram
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Guys and St Thomas NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Humra Chadwick
Phone
02071887188
Ext
56217
Email
humra.chadwick1@gstt.nhs.uk
First Name & Middle Initial & Last Name & Degree
Aldo Rinaldi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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