Temporary Epicardial Cardiac Resynchronisation.

Not Applicable

Completed

• Conditions: Cardiac Failure

• Registration Number: NCT01027299
• Lead Sponsor: Cardiff and Vale University Health Board

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-07
• Status Verified: 2011-06
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government.	30 days

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Cardiff and Vale University Health Board.; 🇬🇧 Cardiff, United Kingdom

Morriston Hospital; 🇬🇧 Swansea, United Kingdom