Temporary Epicardial Cardiac Resynchronisation.

Study Overview
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Brief Summary
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This trial will investigate the clinical and haemodynamic effects of temporary biventricular pacing after cardiac surgery. Subjects with poor left ventricular systolic function will receive either temporary biventricular pacing or 'standard' post-operative pacing for 48 hours. The investigators hypothesis that reversal of cardiac dyssynchrony will improve tissue perfusion and cardiac haemodynamics after surgical revascularisation. This will shorten post-operative recovery in cardiac ITU.

Detailed Description
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Patients with poor left ventricular (LV) function are at higher risk of complications after cardiac surgery, compared to patients with preserved LV function. The higher complication rates also lead to prolonged Cardiac Intensive Care (CITU) admissions for monitoring and multi-organ support. The investigators hypothesise that BiV pacing will reverse cardiac dyssynchrony and improve target organ perfusion. This will be significantly reduced the post operative requirement for Level 3 CITU care. This study will compare 48 hours of temporary biventricular (BiV) pacing to enhance cardiac function against standard post-operative pacing, in patients with poor LV function undergoing cardiac surgery. Temporary biventricular (BiV) pacing will be achieved with the addition of a third pacing electrode attached to the left ventricle. Using a pulmonary arterial catheter the interventricular (VV) delay will be adjusted to yield the maximum cardiac output at constant heart rate- sequential BiV pacing. A pilot study conducted at the University Hospital of Wales (UHW) showed that this approach is likely to be successful. The primary endpoint of the study will be the mean duration of Level 3 CITU care required by patients after cardiac surgery. Secondary endpoints will include: haemodynamic improvement with BiV pacing; post-operative renal function; atrial fibrillation (AF)/ ventricular arrhythmias; post operative inotropic requirements and changes in biomarkers- NT Pro BNP and Troponin T.

Official Title
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A Randomised Study of Temporary Epicardial Cardiac Resynchronisation Versus Conventional Right Ventricular Pacing in Cardiac Surgical Patients.

Conditions
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Cardiac Failure

Intervention / Treatment
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* Device: Biventricular pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary disease scheduled for surgical revascularisation. Ejection fraction <35% (simpson's method.) Exclusion Criteria: Permanent pacemaker or implantable defibrillator. Dialysis dependent renal failure. Permanent atrial fibrillation.

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 pacing<br>Standard pacing settings prescribed by the cardiac surgeon or intensivist after revascularisation. | Device: Biventricular pacing<br>* Optimised temporary biventricular pacing.<br>* Other names: Standard pacing;|
| Active Comparator: BiVentricular pacing (BiV).<br>The group of patients receiving biventricular pacing after cardiac surgery. | Device: Biventricular pacing<br>* Optimised temporary biventricular pacing.<br>* Other names: Standard pacing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 days | 
| Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.) |  | 30 days | 
| Vascular event (stroke or myocardial infarction.) |  | 30 days | 
| post operative arrhythmia. |  | 48 hours | 
| Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor). |  | 48 hours | 
| Renal function and requirement for haemofiltration. |  | 30 days | 
| Biomarkers (Troponin T and NT Pro BNP.) |  | 72 hours | 
| Re-intubation or re-sternotomy. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac failure, thoracic surgery, cardiac pacing, artificial