NCT00916435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

6.8 years

First QC Date

June 8, 2009

Last Update Submit

April 19, 2015

Conditions

Congestive Heart FailureSudden Cardiac DeathArrhythmiaCardiomyopathies

Keywords

ArrhythmiaCardiac ArrestCardiomyopathyHeart Failure

Outcome Measures

Primary Outcomes (1)

  • sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)

    from enrollment up to 72 months

Secondary Outcomes (2)

  • Composite heart failure outcome (HF hospitalization, HF death, heart transplant)

    from enrollment up to 72 months

  • All-cause mortality

    from enrollment up to 72 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation for primary or secondary prevention of sudden cardiac death

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (11)

  • 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.

    PMID: 19808478RESULT

  • 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.

    PMID: 19700170RESULT

  • 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.

    PMID: 19695461RESULT

  • 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.

    PMID: 21087331RESULT

  • 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.

    PMID: 21699842RESULT

  • 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.

    PMID: 21091740RESULT

  • 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.

    PMID: 23416373RESULT

  • 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.

    PMID: 22995383RESULT

  • 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.

    PMID: 25752990RESULT

  • 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.

    PMID: 23964242RESULT

  • 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.

    PMID: 22750217RESULT

MeSH Terms

Conditions

Heart FailureDeath, Sudden, CardiacArrhythmias, CardiacCardiomyopathiesHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Larisa G Tereshchenko, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Ronald D Berger, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Medicine

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 9, 2009

Study Start

March 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

US(2)