Temporary Epicardial Cardiac Resynchronisation.

January 28, 2020 updated by: Cardiff and Vale University Health Board

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Cardiff and Vale University Health Board.
      • Swansea, United Kingdom, SA6 6NL
        • Morriston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff and Vale University Health Board

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (Estimate)

December 7, 2009

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/CAD/4628

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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