Clinical trial NCT00916435: Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms
Official title: Prospective Observational Study of the ICD Intracardiac Electrograms for Prediction of Ventricular Tachyarrhythmias and Congestive Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Sudden Cardiac Death
Arrhythmia
Cardiomyopathies
Keywords: Arrhythmia
Cardiac Arrest
Cardiomyopathy
Heart Failure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2009-06-09
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation for primary or secondary prevention of sudden cardiac death

Brief summary: The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used:

* to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and
* to predict progression of heart failure in patients with ICD.


Eligibility criteria: Inclusion Criteria:

* history of acute MI at least 4 weeks old
* non-ischemic LV dysfunction for at least 9 months
* who have an EF \< or = to 35%
* who was resuscitated from sudden cardiac arrest (ventricular tachyarrhythmia)
* undergone implantation of an FDA-approved ICD for primary or secondary prevention of SCD

Exclusion Criteria:

* inability or unwillingness to provide valid informed consent
* pregnancy
* any condition other than cardiac disease that was associated with a high likelihood of death during 1 year after enrollment

Primary outcomes:
measure: sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)
timeFrame: from enrollment up to 72 months
Secondary outcomes:
measure: Composite heart failure outcome (HF hospitalization, HF death, heart transplant)
timeFrame: from enrollment up to 72 months
measure: All-cause mortality
timeFrame: from enrollment up to 72 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Johns Hopkins University
name: Larisa G Tereshchenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Ronald D Berger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tereshchenko LG, Fetics BJ, Domitrovich PP, Lindsay BD, Berger RD. Prediction of ventricular tachyarrhythmias by intracardiac repolarization variability analysis. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):276-84. doi: 10.1161/CIRCEP.108.829440. Epub 2009 Mar 6.
citation: Tereshchenko LG, Fetics BJ, Berger RD. Intracardiac QT variability in patients with structural heart disease on class III antiarrhythmic drugs. J Electrocardiol. 2009 Nov-Dec;42(6):505-10. doi: 10.1016/j.jelectrocard.2009.07.011. Epub 2009 Aug 22.
citation: Tereshchenko LG, Faddis MN, Fetics BJ, Zelik KE, Efimov IR, Berger RD. Transient local injury current in right ventricular electrogram after implantable cardioverter-defibrillator shock predicts heart failure progression. J Am Coll Cardiol. 2009 Aug 25;54(9):822-8. doi: 10.1016/j.jacc.2009.06.004.
citation: Stempniewicz P, Cheng A, Connolly A, Wang XY, Calkins H, Tomaselli GF, Berger RD, Tereshchenko LG. Appropriate and inappropriate electrical therapies delivered by an implantable cardioverter-defibrillator: effect on intracardiac electrogram. J Cardiovasc Electrophysiol. 2011 May;22(5):554-60. doi: 10.1111/j.1540-8167.2010.01958.x. Epub 2010 Nov 18.
citation: Oosterhoff P, Tereshchenko LG, van der Heyden MA, Ghanem RN, Fetics BJ, Berger RD, Vos MA. Short-term variability of repolarization predicts ventricular tachycardia and sudden cardiac death in patients with structural heart disease: a comparison with QT variability index. Heart Rhythm. 2011 Oct;8(10):1584-90. doi: 10.1016/j.hrthm.2011.04.033. Epub 2011 May 10.
citation: Tereshchenko LG, Henrikson CA, Stempniewicz P, Han L, Berger RD. Antiarrhythmic effect of reverse electrical remodeling associated with cardiac resynchronization therapy. Pacing Clin Electrophysiol. 2011 Mar;34(3):357-64. doi: 10.1111/j.1540-8159.2010.02974.x. Epub 2010 Nov 22.
citation: Chen X, Tereshchenko LG, Berger RD, Trayanova NA. Arrhythmia risk stratification based on QT interval instability: an intracardiac electrocardiogram study. Heart Rhythm. 2013 Jun;10(6):875-80. doi: 10.1016/j.hrthm.2013.02.014. Epub 2013 Feb 13.
citation: Das D, Han L, Berger RD, Tereshchenko LG. QT variability paradox after premature ventricular contraction in patients with structural heart disease and ventricular arrhythmias. J Electrocardiol. 2012 Nov-Dec;45(6):652-7. doi: 10.1016/j.jelectrocard.2012.07.016. Epub 2012 Sep 17.
citation: Baumert M, Kabir MM, Dalouk K, Henrikson CA, Tereshchenko LG. VV' Alternans Triplets on Near-Field ICD Intracardiac Electrogram is Associated with Mortality. Pacing Clin Electrophysiol. 2015 May;38(5):547-57. doi: 10.1111/pace.12594. Epub 2015 Mar 9.
citation: Guduru A, Lansdown J, Chernichenko D, Berger RD, Tereshchenko LG. Longitudinal changes in intracardiac repolarization lability in patients with implantable cardioverter-defibrillator. Front Physiol. 2013 Aug 12;4:208. doi: 10.3389/fphys.2013.00208. eCollection 2013.
citation: Tereshchenko LG, McCabe A, Han L, Sur S, Huang T, Marine JE, Cheng A, Spragg DD, Sinha S, Calkins H, Stein K, Tomaselli GF, Berger RD. Intracardiac J-point elevation before the onset of polymorphic ventricular tachycardia and ventricular fibrillation in patients with an implantable cardioverter-defibrillator. Heart Rhythm. 2012 Oct;9(10):1594-602. doi: 10.1016/j.hrthm.2012.06.036. Epub 2012 Jun 29.