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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03992560

Acronym

TACTIC CRT

Enrollment

218

Registered

2019-06-20

Start date

2019-07-05

Completion date

2026-07-05

Last updated

2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

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).

Interventions

DEVICEGuide 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
>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

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026