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Temporary Epicardial Cardiac Resynchronisation.

Sponsor
Cardiff and Vale University Health Board (Other)
Overall Status
Completed
CT.gov ID
NCT01027299
Collaborator
(none)
31
Enrollment
2
Locations
2
Arms
25
Duration (Months)
15.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Biventricular pacing
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
31 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 :
Dec 1, 2009
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

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 Names:
  • 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 Names:
  • Standard pacing

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Mortality [30 days]

    2. Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.) [30 days]

    3. Vascular event (stroke or myocardial infarction.) [30 days]

    4. post operative arrhythmia. [48 hours]

    5. Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor). [48 hours]

    6. Renal function and requirement for haemofiltration. [30 days]

    7. Biomarkers (Troponin T and NT Pro BNP.) [72 hours]

    8. Re-intubation or re-sternotomy. [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Cardiff and Vale University Health Board. Cardiff United Kingdom CF14 4XW
    2 Morriston Hospital Swansea United Kingdom SA6 6NL

    Sponsors and Collaborators

    • Cardiff and Vale University Health Board

    Investigators

    • Study Director: Zaheer R Yousef, MD, Cardiff and Vale Local Heath Board, Cardiff.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cardiff and Vale University Health Board
    ClinicalTrials.gov Identifier:
    NCT01027299
    Other Study ID Numbers:
    • 09/CAD/4628
    First Posted:
    Dec 7, 2009
    Last Update Posted:
    Jan 29, 2020
    Last Verified:
    Jun 1, 2011
    Keywords provided by Cardiff and Vale University Health Board
    cardiac failure
    thoracic surgery
    cardiac pacing, artificial
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jan 29, 2020