Temporary Epicardial Cardiac Resynchronisation.

Cardiff and Vale University Health Board

Status: Completed

Conditions: Cardiac Failure

Treatments: Device: Biventricular pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT01027299

09/CAD/4628

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Standard pacing

Active Comparator group

Description:

Standard pacing settings prescribed by the cardiac surgeon or intensivist after revascularisation.

Treatment:

Device: Biventricular pacing

BiVentricular pacing (BiV).

Active Comparator group

Description:

The group of patients receiving biventricular pacing after cardiac surgery.

Treatment:

Device: Biventricular pacing