Temporary Epicardial Cardiac Resynchronisation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01027299
Recruitment Status : Unknown
Verified June 2011 by Cardiff and Vale University Health Board.
Recruitment status was:  Recruiting
First Posted : December 7, 2009
Last Update Posted : June 23, 2011
Information provided by:
Cardiff and Vale University Health Board

December 4, 2009
December 7, 2009
June 23, 2011
December 2009
January 2012   (Final data collection date for primary outcome measure)
Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government. [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT01027299 on Archive Site
  • Mortality [ Time Frame: 30 days ]
  • Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.) [ Time Frame: 30 days ]
  • Vascular event (stroke or myocardial infarction.) [ Time Frame: 30 days ]
  • post operative arrhythmia. [ Time Frame: 48 hours ]
  • Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor). [ Time Frame: 48 hours ]
  • Renal function and requirement for haemofiltration. [ Time Frame: 30 days ]
  • Biomarkers (Troponin T and NT Pro BNP.) [ Time Frame: 72 hours ]
  • Re-intubation or re-sternotomy. [ Time Frame: 30 days ]
Same as current
Not Provided
Not Provided
Temporary Epicardial Cardiac Resynchronisation.
A Randomised Study of Temporary Epicardial Cardiac Resynchronisation Versus Conventional Right Ventricular Pacing in Cardiac Surgical Patients.

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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cardiac Failure
Device: Biventricular pacing
Optimised temporary biventricular pacing.
Other Name: Standard pacing
  • Active Comparator: Standard pacing
    Standard pacing settings prescribed by the cardiac surgeon or intensivist after revascularisation.
    Intervention: Device: Biventricular pacing
  • Active Comparator: BiVentricular pacing (BiV).
    The group of patients receiving biventricular pacing after cardiac surgery.
    Intervention: Device: Biventricular pacing

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2012
January 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
Dr Zaheer Yousef, Cardiff and Vale University Health Board
Cardiff and Vale University Health Board
Not Provided
Study Director: Zaheer R Yousef, MD Cardiff and Vale Local Heath Board, Cardiff.
Cardiff and Vale University Health Board
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP