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3D Echocardiographic Assessment of Epicardial Pacing After Cardiopulmonary Bypass.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842762
Recruitment Status : Unknown
Verified April 2018 by Suzanne Flier, MD, Lawson Health Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Suzanne Flier, MD, Lawson Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Disorder of Pacing Function Device: Right ventricular epicardial pacing Procedure: cardiac surgery Device: 3D TEE Device: Pacemaker lead Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Sequence of measurements, during sinus rhythm and during pacing is randomized.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Hemodynamic Effect of Transient Epicardial Right Ventricular Pacing After Cardiopulmonary Bypass, Assessed by Real-time Three-dimensional Echocardiography.
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : December 12, 2017
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Sham Comparator: Non-paced
  • cardiac surgery
  • 3D TEE measurements of systolic dyssynchrony
  • right ventricular epicardial pacemaker lead (off)
Procedure: cardiac surgery
Elective cardiac surgery, with use of cardiopulmonary bypass.

Device: 3D TEE
Intraoperatively, all patients will be monitored by means of TEE
Other Name: three-dimensional transesophageal echocardiography

Device: Pacemaker lead
All patients will have a epicardial pacemaker lead in situ.

Experimental: Paced

The 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)
Device: Right ventricular epicardial pacing
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.

Procedure: cardiac surgery
Elective cardiac surgery, with use of cardiopulmonary bypass.

Device: 3D TEE
Intraoperatively, all patients will be monitored by means of TEE
Other Name: three-dimensional transesophageal echocardiography

Device: Pacemaker lead
All patients will have a epicardial pacemaker lead in situ.




Primary Outcome Measures :
  1. Left ventricular systolic dyssynchrony index (SDI) [ Time Frame: Intraoperative, end of cardiac surgery (duration 10 minutes) ]
    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).


Secondary Outcome Measures :
  1. Ventricular volumes and ejection fraction [ Time Frame: Intraoperative, end of cardiac surgery (duration 10 minutes) ]
    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).

  2. LVOT blood flow [ Time Frame: Intraoperative, end of cardiac surgery (duration 10 minutes) ]
    As a surrogate for cardiac output we will obtain the velocity time integral (VTI) across the left ventricular outflow tract (LVOT)

  3. Presence and severity of mitral regurgitation [ Time Frame: Intraoperative, end of cardiac surgery (duration 10 minutes) ]
    From midesophageal position we will perform a transesophageal echocardiography (TEE) study to interrogate the mitral valve for the presence and severity of mitral regurgitation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842762


Locations
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Canada, Ontario
University Hospital - London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Suzanne Flier, MD
Investigators
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Principal Investigator: Suzanne Flier, MD MSc London Health Sciences Center
Publications:
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Responsible Party: Suzanne Flier, MD, Assistant Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02842762    
Other Study ID Numbers: 108176
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suzanne Flier, MD, Lawson Health Research Institute:
Echocardiography, Three-dimensional
Cardiac Surgical Procedures
Cardiac Pacing, Artificial
Anesthesia