Temporary Epicardial Cardiac Resynchronisation. - Full Text View

Purpose

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.

Condition	Intervention
Cardiac Failure	Device: Biventricular pacing

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomised Study of Temporary Epicardial Cardiac Resynchronisation Versus Conventional Right Ventricular Pacing in Cardiac Surgical Patients.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Heart Surgery

U.S. FDA Resources

Further study details as provided by Cardiff and Vale University Health Board:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	December 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Standard pacing Standard pacing settings prescribed by the cardiac surgeon or intensivist after revascularisation.	Device: Biventricular pacing Optimised temporary biventricular pacing. Other Name: Standard pacing
Active Comparator: BiVentricular pacing (BiV). The group of patients receiving biventricular pacing after cardiac surgery.	Device: Biventricular pacing Optimised temporary biventricular pacing. Other Name: Standard pacing

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027299

Contacts

Contact: Zaheer R Yousef, MD

+442920744474

Zaheer.Yousef@CardiffandVale.wales.nhs.uk

Locations

United Kingdom
Cardiff and Vale University Health Board.	Recruiting
Cardiff, United Kingdom, CF14 4XW
Contact: Zaheer R Yousef, MD +442920744474 Zaheer.Yousef@CardiffandVale.wales.nhs.uk
Sub-Investigator: Stuart J Russell, MB BS
Sub-Investigator: Alan Fraser, MD
Sub-Investigator: Christine Tan, MD
Principal Investigator: Zaheer r Yousef, MD
Morriston Hospital	Recruiting
Swansea, United Kingdom, SA6 6NL
Contact: Afzal Zaidi, MD +4417920 702222 ext 3243 azfral.zaidi@wales.nhs.uk
Principal Investigator: Afzal Zaidid, MD
Sub-Investigator: Stuart J Russell, MBBS

Sponsors and Collaborators

Cardiff and Vale University Health Board

Investigators

Study Director:

Zaheer R Yousef, MD

Cardiff and Vale Local Heath Board, Cardiff.

More Information

No publications provided by Cardiff and Vale University Health Board

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Dr Zaheer Yousef, Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier:	NCT01027299 History of Changes
Other Study ID Numbers:	09/CAD/4628
Study First Received:	December 4, 2009
Last Updated:	June 22, 2011
Health Authority:	United Kingdom: Research Ethics Committee United Kingdom: National Health Service

Keywords provided by Cardiff and Vale University Health Board:

cardiac failure
thoracic surgery
cardiac pacing, artificial

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013