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

Guy's and St Thomas' NHS Foundation Trust

Status

Enrolling

Conditions

Cardiovascular Diseases

Treatments

Device: Guide CRT Software Prototype

Study type

Interventional

Funder types

Other

Identifiers

NCT03992560

1.1

Details and patient eligibility

About

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).

Enrollment

218 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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