Temporary Epicardial Cardiac Resynchronisation.

Cardiac Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027299
• Other study ID #: 09/CAD/4628
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: January 2012

Study information

• Verified date: June 2011
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Failure
• Heart Failure

Intervention

Device:
• Biventricular pacing
Optimised temporary biventricular pacing.

Locations

Country	Name	City	State
United Kingdom	Cardiff and Vale University Health Board.	Cardiff
United Kingdom	Morriston Hospital	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government.		30 days
Secondary	Mortality		30 days
Secondary	Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.)		30 days
Secondary	Vascular event (stroke or myocardial infarction.)		30 days
Secondary	post operative arrhythmia.		48 hours
Secondary	Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor).		48 hours
Secondary	Renal function and requirement for haemofiltration.		30 days
Secondary	Biomarkers (Troponin T and NT Pro BNP.)		72 hours
Secondary	Re-intubation or re-sternotomy.		30 days