Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms

Congestive Heart Failure Clinical Trial

— ICD-EGMs  

Official title:

Prospective Observational Study of the ICD Intracardiac Electrograms for Prediction of Ventricular Tachyarrhythmias and Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916435
• Other study ID #: 1K99HL094665-01 (in review)
• Status: Completed
• Phase: N/A
• First received: June 8, 2009
• Last updated: April 19, 2015
• Start date: March 2005
• Est. completion date: December 2011

Study information

• Verified date: April 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Cardiomyopathies
• Congestive Heart Failure
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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 — View 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. eColle — View 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 v — View 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 — View 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 — View 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. — View 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 200 — View 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.1540-8159.2010.029 — View 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 p — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)		from enrollment up to 72 months	No
Secondary	Composite heart failure outcome (HF hospitalization, HF death, heart transplant)		from enrollment up to 72 months	No
Secondary	All-cause mortality		from enrollment up to 72 months	No