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Temporary Epicardial Cardiac Resynchronisation.

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Cardiff and Vale University Health Board

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.


Condition or disease Intervention/treatment
Cardiac Failure Device: Biventricular 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Study of Temporary Epicardial Cardiac Resynchronisation Versus Conventional Right Ventricular Pacing in Cardiac Surgical Patients.
Study Start Date : December 2009
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
  2. Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.) [ Time Frame: 30 days ]
  3. Vascular event (stroke or myocardial infarction.) [ Time Frame: 30 days ]
  4. post operative arrhythmia. [ Time Frame: 48 hours ]
  5. Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor). [ Time Frame: 48 hours ]
  6. Renal function and requirement for haemofiltration. [ Time Frame: 30 days ]
  7. Biomarkers (Troponin T and NT Pro BNP.) [ Time Frame: 72 hours ]
  8. Re-intubation or re-sternotomy. [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: December 7, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

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