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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Pocono Medical Center
Information provided by (Responsible Party):
Pocono Medical Center Identifier:
First received: September 12, 2013
Last updated: November 1, 2015
Last verified: November 2015
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).

Sudden Cardiac Death

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Pocono Medical Center:

Primary Outcome Measures:
  • Sudden Cardiac Death [ Time Frame: Subjects will be followed for the duration of the study, an expected average of 2.5 years ] [ Designated as safety issue: No ]

    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

Estimated Enrollment: 250
Study Start Date: October 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01948206

Contact: Praveer Jain, M.D. 570-421-4000

United States, Pennsylvania
Pocono Medical Center Physicians Associates-Cardiology Recruiting
East Stroudsburg, Pennsylvania, United States, 18301
Contact: Praveer Jain, M.D.    570-424-9970   
Principal Investigator: Praveer Jain, M.D.         
Sub-Investigator: Jennifer A Chao, M.S.         
Sponsors and Collaborators
Pocono Medical Center
Principal Investigator: Praveer Jain, M.D. Pocono Medical Center
  More Information


Responsible Party: Pocono Medical Center Identifier: NCT01948206     History of Changes
Other Study ID Numbers: PMC001 
Study First Received: September 12, 2013
Last Updated: November 1, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Cardiovascular Diseases
Death, Sudden
Heart Arrest
Heart Diseases
Pathologic Processes processed this record on May 30, 2016