NCT01027299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 29, 2020

Status Verified

June 1, 2011

Enrollment Period

2.1 years

First QC Date

December 4, 2009

Last Update Submit

January 28, 2020

Conditions

Cardiac Failure

Keywords

cardiac failurethoracic surgerycardiac pacing, artificial

Outcome Measures

Primary Outcomes (1)

  • Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government.

    30 days

Secondary Outcomes (8)

  • Mortality

    30 days

  • Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.)

    30 days

  • Vascular event (stroke or myocardial infarction.)

    30 days

  • post operative arrhythmia.

    48 hours

  • Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor).

    48 hours

  • +3 more secondary outcomes

Study Arms (2)

Standard pacing

ACTIVE COMPARATOR

Standard pacing settings prescribed by the cardiac surgeon or intensivist after revascularisation.

Device: Biventricular pacing

BiVentricular pacing (BiV).

ACTIVE COMPARATOR

The group of patients receiving biventricular pacing after cardiac surgery.

Device: Biventricular pacing

Interventions

Biventricular pacingDEVICE

Optimised temporary biventricular pacing.

Also known as: Standard pacing
BiVentricular pacing (BiV).Standard pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary disease scheduled for surgical revascularisation. Ejection fraction \<35% (simpson's method.)

You may not qualify if:

  • Permanent pacemaker or implantable defibrillator. Dialysis dependent renal failure. Permanent atrial fibrillation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cardiff and Vale University Health Board.

Cardiff, CF14 4XW, United Kingdom

Location

Morriston Hospital

Swansea, SA6 6NL, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 23138590DERIVED

  • 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. doi: 10.1186/1745-6215-13-20.

    PMID: 22348447DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Zaheer R Yousef, MD

    Cardiff and Vale Local Heath Board, Cardiff.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 7, 2009

Study Start

December 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 29, 2020

Record last verified: 2011-06

Locations

GB(2)