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

Cardiovascular Diseases Clinical Trial

— TACTIC CRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03992560
• Other study ID #: 1.1
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2019
• Est. completion date: July 5, 2026

Study information

• Verified date: August 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: July 5, 2026
• Est. primary completion date: July 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas NHS Foundation Trust	London

Sponsors (2)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	>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	5% absolute increase in left ventricular ejection fraction	5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram	6 months
Secondary	>10% reduction in end diastolic volume	>10% reduction in end diastolic volume as derived from 2D echocardiogram	6 months