Pressure Wire Guided Cardiac Resynchronisation Therapy

Study Overview
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Brief Summary
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Heart failure patients may benefit from having a special pacemaker implanted that can make the heart pump in a more coordinated and efficient way Cardiac Resynchronisation Therapy (CRT). For the heart to pump well it is necessary for the pacing wires to be placed in optimal positions. Only two thirds of people respond to CRT and this may be because of non-ideal pacing wire position. A potential marker for response is the change in heart pump pressure change over time. The aim of this study is to use a specialised wire in the main pumping chamber of the heart to record the pressure changes with the pacing lead in various positions to determine the optimal position. It is postulated that the improved pressure changes will increase the proportion of responders. Pilot study work has shown that the work is technically feasible and safe. The initial data has been published in a highly regarded scientific journal. This main study will be a multicentre randomised controlled trial whereby patients will be randomised to either standard treatment or pressure wireguided treatment. The patients in the pressurewire guided arm will have a specialised wire implanted into the main pumping chamber of their heart via a blood vessel at the top of the leg (or less commonly a blood vessel in the wrist). This will measure acute pressure changes over time and the pacing lead will be positioned in the site that gives the greatest change in pressure. If the patients in the pressurewire guided arm fare better than those receiving standard treatment it may alter how a large proportion of heart failure patients are treated around the world. The study requires 282 patients and is likely to take two years to complete.

Official Title
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A Prospective Randomised Controlled Trial of Cardiac Resynchronisation Therapy Guided by Invasive dP/dT: Radi-CRT Study

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Standard CRT Implant
* Procedure: Pressure-wire guided CRT implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients fulfilling standard criteria for CRT Ischaemic or non-ischaemic heart failure Exclusion Criteria: Contraindication to pressure wire assessment including: Severe aortic valve disease Mechanical aortic valve replacement Severe peripheral vascular disease LV thrombus

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 CRT Implant<br> | Procedure: Standard CRT Implant<br> <br> |
| Active Comparator: Pressure-wire guided CRT Implant<br> | Procedure: Pressure-wire guided CRT implant<br>* A pressure wire will be sited in the left ventricle to measure dP/dT max. The LV lead position that gives the highest dP/dT max will be the final position used.<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 at 6 months |  | 6 months | 
| Change in clinical composite score at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in echo derived endsystolic volume (ESV) at six months |  | 6 months | 
| Change in echo derived enddiastolic colume (EDV) at six months |  | 6 months | 
| Change in echo derived left ventricular ejection fraction (LVEF) at 6 months |  | 6 months | 
| Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire) |  | 6 months | 
| Six month change in 6 minute walk distance |  | 6 months | 
| Six month change in VO2 max (CPET) |  | 6 months | 
| Six month change in ntProBNP |  | 6 months | 
| Six month difference in hospital readmission (days) |  | 6 months | 
| Six month difference in mortality |  | 6 months | 
| Difference in rates of successful LV lead implantation |  | One week | 
| Difference in procedure duration |  | One week | 
| Difference in radiation dose |  | One week | 
| Difference in contrast dose |  | One week | 
| Procedural complications |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Cardiac resynchronisation therapy, Acute haemodynamic response, Responder