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Completed

NCT Number: NCT01027299

Temporary Epicardial Cardiac Resynchronisation.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiff and Vale University Health Board., Cardiff, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biventricular Pacing

Device

Optimised temporary biventricular pacing.

Other names: Standard pacing

Primary outcomes

  1. Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government.

    Time frame: 30 days

Secondary outcomes

  1. Mortality

    Time frame: 30 days

  2. Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.)

    Time frame: 30 days

  3. Vascular event (stroke or myocardial infarction.)

    Time frame: 30 days

  4. post operative arrhythmia.

    Time frame: 48 hours

  5. Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor).

    Time frame: 48 hours

  6. Renal function and requirement for haemofiltration.

    Time frame: 30 days

  7. Biomarkers (Troponin T and NT Pro BNP.)

    Time frame: 72 hours

  8. Re-intubation or re-sternotomy.

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Cardiff and Vale University Health Board

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 7, 2009
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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