Ventricular Synchrony in Pediatric Patients

This study has been completed.

Sponsor:

Collaborator:

Children's Healthcare of Atlanta

Information provided by (Responsible Party):

Patricio A. Frias, MD, Emory University

ClinicalTrials.gov Identifier:

NCT00165932

First received: September 9, 2005

Last updated: May 30, 2012

Last verified: May 2012

History of Changes

Purpose

At Children's Healthcare of Atlanta, children who have irregular heart rhythms are often referred for evaluation. Sometimes they also need a procedure to correct their irregular heart rhythm. An echocardiogram is routinely used as part of their evaluation and follow-up. The echocardiogram including Tissue Doppler Imaging (TDI) works by bouncing sound waves off the heart similar to radar. A new echocardiogram technology, Tissue Synchronization Imaging (TSI), should help doctors look at heart function compared to heart rhythm. All three of these are noninvasive, which means they work from a probe outside the body and are not painful.

The purpose of this study is to see how Tissue Synchronization Imaging works in patients with heart rhythm problems. We will use patients who have a heart irregularity. We will also look at children and young adults with normal heart function to establish normal values for TSI.

All pediatric patients we approach for this study will receive an echocardiogram recommended by their cardiologist (standard of care), plus TSI, a new part of a heart ultrasound The young adult population will undergo a heart ultrasound plus TSI. This young adult population will be selected from medical students at Emory University. During the consent process, the medical students will be informed that participation is voluntary and if they decide not to participate, it will not affect their grades, etc.

Condition
Irregular Heart Rate

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	A Single Center Prospective, Pilot Study Examining the Non-invasive Evaluation of Ventricular Synchrony in Pediatric Patients

Further study details as provided by Emory University:

Enrollment:	145
Study Start Date:	June 2004
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

We are currently only enrolling those patients with the diagnosis of SVT who are scheduled for an electrophysical study at Children's Healthcare of Atlanta Egleston Campus.

Criteria

Inclusion Criteria:

Any pediatric patient already referred for EPS and possible RFA at Children's Healthcare of Atlanta for the following diagnoses:

Non-preexcited supraventricular tachycardia
Atrioventricular Node Reentrant Tachycardia (AVNRT)
Atrioventricular Reentry Tachycardia (AVRT) utilizing a concealed AC
Atrial Flutter
Wolff-Parkinson-White syndrome (WPW)
Ventricular tachycardia with structurally normal hearts with normal function We will also be enrolling young adult subjects who will be recruited for participation. -

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165932

Locations

United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Children's Healthcare of Atlanta

Investigators

Principal Investigator:

Patricio Frias, MD

Emory University

More Information

Publications:

Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. 2003 Aug 20;42(4):614-23.

Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23.

Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53.

Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC; Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001 Mar 22;344(12):873-80.

Responsible Party:	Patricio A. Frias, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier:	NCT00165932 History of Changes
Other Study ID Numbers:	417-2004
Study First Received:	September 9, 2005
Last Updated:	May 30, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

tachycardia
pediatrics

ClinicalTrials.gov processed this record on May 22, 2013

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