Cardiac FailureNCT01027299
Temporary Epicardial Cardiac Resynchronisation.
A study testing Biventricular pacing in people with Cardiac Failure, run by Cardiff and Vale University Health Board at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Failure
- What is being tested?
- Biventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Dec 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary disease scheduled for surgical revascularisation. Ejection fraction <35% (simpson's method.)
Who cannot join
- Permanent pacemaker or implantable defibrillator. Dialysis dependent renal failure. Permanent atrial fibrillation.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cardiff and Vale University Health Board.
Cardiff, CF14 4XW
Morriston Hospital
Swansea, SA6 6NL
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Failure
- Being tested
- Biventricular pacing
- Keywords
- cardiac failure, thoracic surgery, cardiac pacing, artificial
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biventricular pacingDevice
Also called Standard pacing
Optimised temporary biventricular pacing.
| Study group | Role | What they receive |
|---|---|---|
| Standard pacing | Active comparator | Standard pacing settings prescribed by the cardiac surgeon or intensivist after revascularisation. Receives: Device: Biventricular pacing |
| BiVentricular pacing (BiV). | Active comparator | The group of patients receiving biventricular pacing after cardiac surgery. Receives: Device: Biventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government.
Measured: 30 days
Secondary outcomes (8)
Mortality
Measured: 30 days
Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.)
Measured: 30 days
Vascular event (stroke or myocardial infarction.)
Measured: 30 days
post operative arrhythmia.
Measured: 48 hours
Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor).
Measured: 48 hours
Renal function and requirement for haemofiltration.
Measured: 30 days
Biomarkers (Troponin T and NT Pro BNP.)
Measured: 72 hours
Re-intubation or re-sternotomy.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zaheer R Yousef, MD, Study director, Cardiff and Vale Local Heath Board, Cardiff.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027299
- Sponsor's protocol ID
- 09/CAD/4628
- Status last verified
- Jun 2011
- First submitted
- 4 Dec 2009
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23138590Russell 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.
PubMed 22348447
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study of Temporary Epicardial Cardiac Resynchronisation Versus Conventional Right Ventricular Pacing in Cardiac Surgical Patients.
- ClinicalTrials.gov ID
- NCT01027299
- Acronym / sponsor ID
- 09/CAD/4628
- Conditions
- Cardiac Failure
- Keywords
- cardiac failure, thoracic surgery, cardiac pacing, artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- Dec 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard pacing | Active comparator | Device: Biventricular pacingStandard pacing settings prescribed by the cardiac surgeon or intensivist after revascularisation. |
| BiVentricular pacing (BiV). | Active comparator | Device: Biventricular pacingThe group of patients receiving biventricular pacing after cardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coronary disease scheduled for surgical revascularisation. Ejection fraction <35% (simpson's method.)
Key exclusion criteria (1 listed)
- Permanent pacemaker or implantable defibrillator. Dialysis dependent renal failure. Permanent atrial fibrillation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biventricular pacingAlso: Standard pacingOptimised temporary biventricular pacing. | Device | BiVentricular pacing (BiV)., Standard pacing |
Primary outcome
Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government.
Time frame: 30 days
8 secondary outcomes
Mortality
Time frame: 30 days
Haemodynamic support after surgery (inotropes/ intra-aortic balloon pump.)
Time frame: 30 days
Vascular event (stroke or myocardial infarction.)
Time frame: 30 days
post operative arrhythmia.
Time frame: 48 hours
Haemodynamic measurements of cardiac status (Pulmonary arterial catheter, echo data and FloTrac monitor).
Time frame: 48 hours
Renal function and requirement for haemofiltration.
Time frame: 30 days
Biomarkers (Troponin T and NT Pro BNP.)
Time frame: 72 hours
Re-intubation or re-sternotomy.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Derived from this study: PubMed 23138590Russell 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.
- Derived from this study: PubMed 22348447Russell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaheer R Yousef, MD study director
Cardiff and Vale Local Heath Board, Cardiff.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biventricular pacing in people with Cardiac Failure, run by Cardiff and Vale University Health Board at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Level 3 care after cardiac surgery, as defined by the 'Designed for Life' document- Welsh Assembly Government. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01027299, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.