PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial

Study Overview
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Brief Summary
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Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms in patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to improve LV function in patients with heart failure if those regions of the myocardium which are most compromised by electromechanical dyssynchrony can be identified and effectively stimulated. There still remains, however, a significant rate of up to 30% of patients who do not respond to treatment. Reasons for lack of benefit can be related to the inability of identifying and effectively stimulating those regions of myocardium, which are most compromised by electromechanical dyssynchrony. The investigators hypothesize that by using cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and determine the site of latest LV activation, the investigators can find the best place to implant the left ventricular lead. By avoiding scar and pacing in the site of latest activation, the investigators believe the investigators will reduce dyssynchrony and thus improve overall heart function. The researchers thus aim to increase the proportion of people who respond to treatment. The researchers also believe that the procedure may be streamlined so as to reduce procedure duration, radiation dose and dose of iodinated contrast medium.

Official Title
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A Prospective Randomised Study of Advanced Imaging Guided Cardiac Resynchronisation Therapy (CRT) vs Conventional CRT Implantation in Patients With Chronic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Advanced Imaging Guided LV lead placement
* Device: Standard LV lead placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18yrs of age Standard indication for CRT=P or CRT=D according to NICE criteria (Clinical symptoms of heart failure despite medical therapy, broad QRS >120ms and significant LV dysfunction LEF <35%) Stable on optimal medical therapy for at least 3 months No exclusion to pacing /ICD Ischaemic or non-ischaemic aetiology Exclusion Criteria: Any contraindication to pacing /ICD implant Contraindication to MR scanning Claustrophobia Significant renal impairment (estimated GFR <30)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard LV lead placement<br> | Device: Standard LV lead placement<br>* Standard LV lead placement not guided by advanced imaging<br>|
| Experimental: Advanced Imaging Guided LV Lead Placement<br> | Other: Advanced Imaging Guided LV lead placement<br>* Use of MRI to identify scar and latest activating LV segment as well as CS anatomy. This will be used to guide LV lead placement real-time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the proportion of CRT responders |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in echo derived end systolic (ESV) and diastolic volumes |  | 6 months | 
| Six month assessment of change in 6 minute walk distance and VO2 max (CPEX) |  | 6 months | 
| Procedural success |  | 0 months | 
| Procedure duration |  | 0 months | 
| Radiation dose |  | 0 months | 
| Contrast dose |  | 0 months | 
| Procedural complications |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac resychronisation therapy, Heart failure, Imaging guided LV lead placement