Clinical trial NCT01027299: Temporary Epicardial Cardiac Resynchronisation.
Official title: A Randomised Study of Temporary Epicardial Cardiac Resynchronisation Versus Conventional Right Ventricular Pacing in Cardiac Surgical Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Failure
Keywords: cardiac failure
thoracic surgery
cardiac pacing, artificial
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
First posted: 2009-12-07
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government.
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.)
timeFrame: 30 days
measure: Vascular event (stroke or myocardial infarction.)
timeFrame: 30 days
measure: post operative arrhythmia.
timeFrame: 48 hours
measure: Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor).
timeFrame: 48 hours
measure: Renal function and requirement for haemofiltration.
timeFrame: 30 days
measure: Biomarkers (Troponin T and NT Pro BNP.)
timeFrame: 72 hours
measure: Re-intubation or re-sternotomy.
timeFrame: 30 days
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board.
city: Swansea
country: United Kingdom
facility: Morriston Hospital
Study officials:
affiliation: Cardiff and Vale Local Heath Board, Cardiff.
name: Zaheer R Yousef, MD
role: STUDY_DIRECTOR
References:
citation: Russell SJ, Tan C, O'Keefe P, Ashraf S, Zaidi A, Fraser AG, Yousef ZR. Optimized temporary bi-ventricular pacing improves haemodynamic function after on-pump cardiac surgery in patients with severe left ventricular systolic dysfunction: a two-centre randomized control trial. Eur J Cardiothorac Surg. 2012 Dec;42(6):e146-51. doi: 10.1093/ejcts/ezs492.
citation: Russell SJ, Tan C, O'Keefe P, Ashraf S, Zaidi A, Fraser AG, Yousef ZR. Temporary epicardial cardiac resynchronisation versus conventional right ventricular pacing after cardiac surgery: study protocol for a randomised control trial. Trials. 2012 Feb 20;13:20. doi: 10.1186/1745-6215-13-20.