NCT00733590

Brief Summary

The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at high risk of sudden cardiac death (SCD). Such information may be used to better define patients most likely to benefit from replacement of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD pulse generator replacement for primary prevention of SCD (PROSe-ICD) was established to :

  1. 1.to gain a better understanding of the biological mechanisms that predispose to SCD
  2. 2.to develop readily determined clinical, electrocardiographic, genetic and blood protein markers identify patients with an increased risk of dying suddenly

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

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 Progress89%
Jun 2003Mar 2029

Study Start

First participant enrolled

June 1, 2003

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
19.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

24.8 years

First QC Date

August 11, 2008

Last Update Submit

January 15, 2026

Conditions

Heart Failure, CongestiveDeath, Sudden, CardiacArrhythmiaCardiomyopathies

Keywords

defibrillator, implantedgenomicselectrocardiographyelectrophysiological studyproteomics

Outcome Measures

Primary Outcomes (1)

  • Arrhythmic Sudden Death defined as a therapy from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD

    10 years

Secondary Outcomes (1)

  • All cause mortality, cardiovascular (CV) mortality, heart transplant, left ventricular assist device (LVAD), and implantable cardioverter defibrillator (ICD) explantation, or ICD Disabled

    Total period of observation in the study

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ischemic or non-ischemic cardiomyopathy undergoing their initial ICD implant for primary prevention, or programmed generator replacements on participants originally implanted for primary prevention.

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 ejection fraction (EF) \< or = to 35%
  • Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment.
  • Who have primary prevention implants.

You may not qualify if:

  • ICD generator replacement for secondary prevention
  • Inability or unwillingness to provide valid informed consent
  • New York Heart Association Class IV heart failure
  • Patients with pre-existing Class 1 indications for pacemaker therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

Virginia Commonwealth University School of Medicine

Richmond, Virginia, 23298, United States

RECRUITING

Related Publications (7)

  • Gokhale TA, Dey S, Limpitikul WB, Gautam N, Al'Aref SJ, Cross B, Saba S, Estes NAM 3rd, Vaughan BL, Jones SR, Tomaselli GF, Wu KC, DeMazumder D. Combined Analysis of Cardiac Repolarization Entropy and Magnetic Resonance Imaging Enhances Risk Stratification of Patients Receiving a Primary-Prevention ICD. JACC Clin Electrophysiol. 2026 Feb 24:S2405-500X(26)00126-X. doi: 10.1016/j.jacep.2026.01.051. Online ahead of print.

    PMID: 41823943DERIVED

  • Nauffal V, Zhang Y, Tanawuttiwat T, Blasco-Colmenares E, Rickard J, Marine JE, Butcher B, Norgard S, Dickfeld TM, Ellenbogen KA, Guallar E, Tomaselli GF, Cheng A. Clinical decision tool for CRT-P vs. CRT-D implantation: Findings from PROSE-ICD. PLoS One. 2017 Apr 7;12(4):e0175205. doi: 10.1371/journal.pone.0175205. eCollection 2017.

    PMID: 28388657DERIVED

  • Cheng A, Zhang Y, Blasco-Colmenares E, Dalal D, Butcher B, Norgard S, Eldadah Z, Ellenbogen KA, Dickfeld T, Spragg DD, Marine JE, Guallar E, Tomaselli GF. Protein biomarkers identify patients unlikely to benefit from primary prevention implantable cardioverter defibrillators: findings from the Prospective Observational Study of Implantable Cardioverter Defibrillators (PROSE-ICD). Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1084-91. doi: 10.1161/CIRCEP.113.001705. Epub 2014 Oct 1.

    PMID: 25273351DERIVED

  • Cheng A, Dalal D, Butcher B, Norgard S, Zhang Y, Dickfeld T, Eldadah ZA, Ellenbogen KA, Guallar E, Tomaselli GF. Prospective observational study of implantable cardioverter-defibrillators in primary prevention of sudden cardiac death: study design and cohort description. J Am Heart Assoc. 2013 Feb 22;2(1):e000083. doi: 10.1161/JAHA.112.000083.

    PMID: 23525420DERIVED

  • Tereshchenko LG, Cheng A, Fetics BJ, Butcher B, Marine JE, Spragg DD, Sinha S, Dalal D, Calkins H, Tomaselli GF, Berger RD. A new electrocardiogram marker to identify patients at low risk for ventricular tachyarrhythmias: sum magnitude of the absolute QRST integral. J Electrocardiol. 2011 Mar-Apr;44(2):208-16. doi: 10.1016/j.jelectrocard.2010.08.012. Epub 2010 Nov 20.

    PMID: 21093871DERIVED

  • 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: 21087331DERIVED

  • Tereshchenko LG, Han L, Cheng A, Marine JE, Spragg DD, Sinha S, Dalal D, Calkins H, Tomaselli GF, Berger RD. Beat-to-beat three-dimensional ECG variability predicts ventricular arrhythmia in ICD recipients. Heart Rhythm. 2010 Nov;7(11):1606-13. doi: 10.1016/j.hrthm.2010.08.022. Epub 2010 Sep 29.

    PMID: 20816873DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood drawn at 6-12 month intervals

MeSH Terms

Conditions

Heart FailureDeath, Sudden, CardiacArrhythmias, CardiacCardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katherine C Wu, MD

    Associate Professor of Medicine Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Wu, MD

CONTACT

410-502-7283kwu@jhmi.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

June 1, 2003

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

US(4)