AzTrials
AzTrials

Disorder of Pacing FunctionNCT02842762

3D Echocardiographic Assessment of Epicardial Pacing After Cardiopulmonary Bypass.

A study testing Right ventricular epicardial pacing, cardiac surgery and 3D TEE in people with Disorder of Pacing Function, run by Suzanne Flier, MD at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study evaluates the usefulness of 3D echocardiography to guide pacemaker therapy in the operating room in cardiac surgical patients. Each patient will serve as his own control, following a paired design. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Disorder of Pacing Function
What is being tested?
Right ventricular epicardial pacing, cardiac surgery and 3D TEE
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteCanada
Study dates
20 Mar 2017to Aug 2018
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

  • Adult patient scheduled to undergo elective cardiac surgery by means of full sternotomy and use of cardiopulmonary bypass
  • Preoperative moderate to good LV function, ejection fraction > 30%
  • Age > 18 yrs. old
  • Preoperative sinus rhythm
  • Pacemaker lead inserted by cardiac surgeon during surgery
  • Underlying sinus rhythm after cardiopulmonary bypass before the end of surgery
  • Able to understand written and verbal patient information
  • Signed informed consent

Who cannot join

  • Emergency cardiac surgery
  • Minimally invasive surgery
  • Contraindication to TEE
  • Redo surgery
  • Hemodynamic instability after CPB (late exclusion criterium)
  • No pacemaker lead inserted by cardiac surgeon (late exclusion criterium)
  • No sinus rhythm during chest closure towards the end of surgery (late exclusion criterium)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Hospital - London Health Sciences Centre

    London, Ontario, N6A 5A5

Other trials in Canada

About this study

Official title: The Hemodynamic Effect of Transient Epicardial Right Ventricular Pacing After Cardiopulmonary Bypass, Assessed by Real-time Three-dimensional Echocardiography.

This study evaluates the usefulness of 3D echocardiography to guide pacemaker therapy in the operating room in cardiac surgical patients. Each patient will serve as his own control, following a paired design.

Read the detailed description

Cardiac surgical patients sometimes require temporary pacing wires to optimize cardiac function during weaning from cardiopulmonary bypass (CPB), and/or to treat hemodynamically significant brady-arrhythmias. The available patient series report that 8.6% to 23.9% of patient undergoing coronary artery bypass grafting (CABG) or valve surgery require temporary pacing at some time after CPB. The site of pacemaker wire placement seems to be a crucial determinant of cardiac output. In non-surgical patients isolated right ventricular (RV) pacing seems to induce electromechanical dyssynchrony of the RV and the left ventricle (LV). A normal ventricle in sinus rhythm displays a simultaneous contraction of all segments of the heart, so that regional minimal volume (i.e. maximal contraction) will occur at the same time. Isolated RV pacing seems to result in a left bundle branch type electrical activation sequence, with delayed contraction of some of the segments. The LV, but not the RV, seems to negatively affected by this state of dyssynchrony, resulting in decreased cardiac output. In surgical patients however, there is not such data available yet. Since isolated RV epicardial wire placement is still widely practiced in cardiac surgery, and in our own institution, we would like to study the effect of RV pacing on LV synchrony and LV output.

Again from studies in non-surgical patients receiving resynchronization therapy, we know that real-time three-dimensional (3D) echocardiography is very useful to pick up subtle changes in LV synchrony and thereby guide synchronization of ventricular contraction. However, to date the usefulness of real-time 3D echocardiography to guide pacemaker therapy in cardiac surgery is unknown. In the present feasibility study in cardiac surgical patients, we want to investigate the acute effects of isolated RV pacing on LV synchrony, and LV output.

Being tested
Right ventricular epicardial pacing, cardiac surgery, 3D TEE, Pacemaker lead
Keywords
Echocardiography, Three-dimensional, Cardiac Surgical Procedures, Cardiac Pacing, Artificial, Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Right ventricular epicardial pacingDevice

    The patient's own heart rate at that moment will be the starting point for the study. Right ventricle pacing will be instituted by selecting a rate that is 5 beats above the patient's own heart rate. We will use a stepwise approach where we increase the pacermaker's rate with steps of 5 beats until we have 100% capture of the pacemaker beats. After waiting for at least one minute of pacing we will obtain a set of measurements.

  • cardiac surgeryProcedure or surgery

    Elective cardiac surgery, with use of cardiopulmonary bypass.

  • 3D TEEDevice

    Also called three-dimensional transesophageal echocardiography

    Intraoperatively, all patients will be monitored by means of TEE

  • Pacemaker leadDevice

    All patients will have a epicardial pacemaker lead in situ.

Study groups in NCT02842762
Study groupRoleWhat they receive
Non-pacedSham comparator* cardiac surgery * 3D TEE measurements of systolic dyssynchrony * right ventricular epicardial pacemaker lead (off)
Receives: Procedure: cardiac surgery; Device: 3D TEE; Device: Pacemaker lead
PacedExperimentalThe patient is randomized to the order of measurements taken, and serves as his own control. * cardiac surgery * 3D TEE measurements of systolic dyssynchrony * right ventricular epicardial pacemaker lead (on)
Receives: Device: Right ventricular epicardial pacing; Procedure: cardiac surgery; Device: 3D TEE; Device: Pacemaker lead

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular systolic dyssynchrony index (SDI)

    For each segment of 16 segments excluding the apical cap in a standard 17-segment model, the time to reach regional minimal volume is calculated as a fraction of the total cardiac cycle (RR interval) and expressed as a percentage.10 The standard deviation of these measurements is defined as the SDI. Three-dimensional SDI is therefore the dispersion time to reach the minimum systolic volume (as recommended).

    Measured: Intraoperative, end of cardiac surgery (duration 10 minutes)

Secondary outcomes (3)

  1. Ventricular volumes and ejection fraction

    We will obtain a full volume 3D dataset and obtain end diastolic (EDV) and end systolic volume (ESV). By subtracting ESV from EDV we will obtain the ejection fraction (EF).

    Measured: Intraoperative, end of cardiac surgery (duration 10 minutes)

  2. LVOT blood flow

    As a surrogate for cardiac output we will obtain the velocity time integral (VTI) across the left ventricular outflow tract (LVOT)

    Measured: Intraoperative, end of cardiac surgery (duration 10 minutes)

  3. Presence and severity of mitral regurgitation

    From midesophageal position we will perform a transesophageal echocardiography (TEE) study to interrogate the mitral valve for the presence and severity of mitral regurgitation.

    Measured: Intraoperative, end of cardiac surgery (duration 10 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2016 (estimated)
  2. Study start20 Mar 2017
  3. Primary completion12 Dec 2017
  4. Study completionAug 2018 (estimated)

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Model description
Sequence of measurements, during sinus rhythm and during pacing is randomized.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02842762
Sponsor's protocol ID
108176
Status last verified
Apr 2018
First submitted
20 Jul 2016
Last updated
12 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wolber T, Haegeli L, Huerlimann D, Brunckhorst C, Luscher TF, Duru F. Altered left ventricular contraction pattern during right ventricular pacing: assessment using real-time three-dimensional echocardiography. Pacing Clin Electrophysiol. 2011 Jan;34(1):76-81. doi: 10.1111/j.1540-8159.2010.02908.x. Epub 2010 Oct 14.

    PubMed 20946287

  • Kapetanakis S, Kearney MT, Siva A, Gall N, Cooklin M, Monaghan MJ. Real-time three-dimensional echocardiography: a novel technique to quantify global left ventricular mechanical dyssynchrony. Circulation. 2005 Aug 16;112(7):992-1000. doi: 10.1161/CIRCULATIONAHA.104.474445. Epub 2005 Aug 8.

    PubMed 16087800

  • Alwaqfi NR, Ibrahim KS, Khader YS, Baker AA. Predictors of temporary epicardial pacing wires use after valve surgery. J Cardiothorac Surg. 2014 Feb 12;9:33. doi: 10.1186/1749-8090-9-33.

    PubMed 24521215

  • Bethea BT, Salazar JD, Grega MA, Doty JR, Fitton TP, Alejo DE, Borowicz LM Jr, Gott VL, Sussman MS, Baumgartner WA. Determining the utility of temporary pacing wires after coronary artery bypass surgery. Ann Thorac Surg. 2005 Jan;79(1):104-7. doi: 10.1016/j.athoracsur.2004.06.087.

    PubMed 15620924

Questions about this trial

What is this clinical trial studying?

A study testing Right ventricular epicardial pacing, cardiac surgery and 3D TEE in people with Disorder of Pacing Function, run by Suzanne Flier, MD at 1 site in Canada.

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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Left ventricular systolic dyssynchrony index (SDI) (time frame: Intraoperative, end of cardiac surgery (duration 10 minutes)). 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 NCT02842762, which also lists 4 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 12 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in