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Temporary Epicardial Cardiac Resynchronisation.

This study is currently recruiting participants.
Verified June 2011 by Cardiff and Vale University Health Board
Sponsor:
Information provided by:
Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier:
NCT01027299
First received: December 4, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes

December 4, 2009
June 22, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01027299 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Vascular event (stroke or myocardial infarction.) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • post operative arrhythmia. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor). [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Renal function and requirement for haemofiltration. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Biomarkers (Troponin T and NT Pro BNP.) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Re-intubation or re-sternotomy. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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.
Both
18 Years and older
No
Contact: Zaheer R Yousef, MD +442920744474 Zaheer.Yousef@CardiffandVale.wales.nhs.uk
United Kingdom
 
NCT01027299
09/CAD/4628
No
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