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

Sponsor

Guy's and St Thomas' NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT03992560

Collaborator

King's College London (Other)

218

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Device: Guide CRT Software Prototype	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

218 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 5, 2019

Anticipated Primary Completion Date :

Jul 5, 2024

Anticipated Study Completion Date :

Jul 5, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

>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

5% absolute increase in left ventricular ejection fraction [6 months]
5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram
>10% reduction in end diastolic volume [6 months]
>10% reduction in end diastolic volume as derived from 2D echocardiogram

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guys and St Thomas NHS Foundation Trust	London		United Kingdom	SE1 7EH

Sponsors and Collaborators

Guy's and St Thomas' NHS Foundation Trust
King's College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guy's and St Thomas' NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT03992560

Other Study ID Numbers:

First Posted:

Jun 20, 2019

Last Update Posted:

Aug 9, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Cardiomyopathies

Study Results

No Results Posted as of Aug 9, 2021