3D Echocardiographic Assessment of Epicardial Pacing After Cardiopulmonary Bypass.

NCT02842762 | Unknown

• 1 other identifier: 108176
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Pacing Function

Keywords

Echocardiography, Three-dimensional; Cardiac Surgical Procedures; Cardiac Pacing, Artificial; Anesthesia

Outcome Measures

Primary Outcomes (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).

  Intraoperative, end of cardiac surgery (duration 10 minutes)

Secondary Outcomes (3)

• Ventricular volumes and ejection fraction

  Intraoperative, end of cardiac surgery (duration 10 minutes)

• LVOT blood flow

  Intraoperative, end of cardiac surgery (duration 10 minutes)

• Presence and severity of mitral regurgitation

  Intraoperative, end of cardiac surgery (duration 10 minutes)

Study Arms (2)

Non-paced

SHAM COMPARATOR

* cardiac surgery * 3D TEE measurements of systolic dyssynchrony * right ventricular epicardial pacemaker lead (off)

Procedure: cardiac surgery; Device: 3D TEE; Device: Pacemaker lead

Paced

EXPERIMENTAL

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; Procedure: cardiac surgery; Device: 3D TEE; Device: Pacemaker lead

Interventions

Right ventricular epicardial pacing DEVICE

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.

Paced

cardiac surgery PROCEDURE

Elective cardiac surgery, with use of cardiopulmonary bypass.

Non-paced; Paced

3D TEE DEVICE

Intraoperatively, all patients will be monitored by means of TEE

Also known as: three-dimensional transesophageal echocardiography

Non-paced; Paced

Pacemaker lead DEVICE

All patients will have a epicardial pacemaker lead in situ.

Non-paced; Paced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Emergency cardiac surgery
• Minimally invasive surgery
• Contraindication to TEE
• Redo surgery

Sponsors & Collaborators

• Suzanne Flier, MD: lead

Study Sites (1)

University Hospital - London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (4)

• 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.

  PMID: 20946287 BACKGROUND

• 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.

  PMID: 16087800 BACKGROUND

• 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.

  PMID: 24521215 BACKGROUND

• 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.

  PMID: 15620924 BACKGROUND

MeSH Terms

Interventions

Cardiac Surgical Procedures; Device Lead Extraction

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Device Removal

Study Officials

• Suzanne Flier, MD MSc

  London Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Sequence of measurements, during sinus rhythm and during pacing is randomized.

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 25, 2016
• Study Start: March 20, 2017
• Primary Completion: December 12, 2017
• Study Completion: August 1, 2018
• Last Updated: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)