Study of Paced QRS Duration as a Marker of Sudden Cardiac Death

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01948206
Recruitment Status : Terminated (Ran out of funds)
First Posted : September 23, 2013
Last Update Posted : December 13, 2016
Information provided by (Responsible Party):
Pocono Medical Center

Brief Summary:
The purpose of the study is to determine whether prolonged paced QRS duration is a marker of sudden cardiac death in subjects with implantable cardioverter-defibrillators (ICD).

Condition or disease
Sudden Cardiac Death

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Prolonged Paced QRS Duration as a Marker of Sudden Cardiac Death in Subjects With Implantable Cardioverter-defibrillators
Study Start Date : October 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Prolonged paced QRS group
Patients with implantable cardioverter-defibrillators with Prolonged Paced(>=150ms) QRS duration
Narrow paced QRS group
Patients with Implantable Cardioverter-Defibrillators with Narrow Paced(<150ms) QRS duration

Primary Outcome Measures :
  1. Sudden Cardiac Death [ Time Frame: Subjects will be followed for the duration of the study, an expected average of 2.5 years ]

    Subjects will be considered to have suffered SCD if they meet one of the following criteria.

    • An appropriate ICD therapy (shock or anti-tachycardia pacing)
    • Death occurring within one hour of onset of cardiac symptoms
    • Death during sleep
    • Unwitnessed death in a formerly stable patient
    • Death during attempted resuscitation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects followed in the ICD clinic at Pocono Medical Center.

Inclusion Criteria:

  • 18 years old or older
  • Male or female
  • Subjects followed in the ICD clinic at Pocono Medical Center who have undergone ICD implantation within 3 years prior to the date of enrollment, and those who undergo ICD implantation during the enrollment period, whether for primary prevention or for secondary prevention based on standard indications will be included in the study.
  • Patients with single chamber, dual chamber and biventricular devices manufactured by all three major vendors (Boston Scientific, St Jude Medical and Medtronic) will be considered.

Exclusion Criteria:

  • Life expectancy of less than one year
  • Severe reaction to the adhesive material on ECG patches

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01948206

United States, Pennsylvania
Pocono Medical Center Physicians Associates-Cardiology
East Stroudsburg, Pennsylvania, United States, 18301
Sponsors and Collaborators
Pocono Medical Center
Principal Investigator: Praveer Jain, M.D. Pocono Medical Center

Publications of Results:

Other Publications:

Responsible Party: Pocono Medical Center Identifier: NCT01948206     History of Changes
Other Study ID Numbers: PMC001
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pocono Medical Center:
Sudden Cardiac Death
Implantable Cardioverter-Defibrillator
Prolonged Paced QRS Duration

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden