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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Pocono Medical Center
Sponsor:
Information provided by (Responsible Party):
Pocono Medical Center
ClinicalTrials.gov Identifier:
NCT01948206
First received: September 12, 2013
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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
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)
Groups/Cohorts
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

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01948206

Contacts
Contact: Praveer Jain, M.D. 570-421-4000 pjain@pmchealthsystem.org

Locations
United States, Pennsylvania
Pocono Medical Center Physicians Associates-Cardiology Not yet recruiting
East Stroudsburg, Pennsylvania, United States, 18301
Contact: Praveer Jain, M.D.    570-424-9970    pjain@pmchealthsystem.org   
Principal Investigator: Praveer Jain, M.D.         
Sub-Investigator: Jennifer A Chao, M.S.         
Sponsors and Collaborators
Pocono Medical Center
Investigators
Principal Investigator: Praveer Jain, M.D. Pocono Medical Center
  More Information

Publications:
Roger VL, Go AS, Lloyd-Jones DM. Executive Summary: Heart disease and stroke statistics-2012 update: A report from the American Heart Association. Circulation 2012:125(1):188-197.
Koyak Z, Harris L, de Groot JR, Silversides CK, Oechslin EN, Bouma BJ, Budts W, Zwinderman AH, Van Gelder IC, Mulder BJ. Sudden cardiac death in adult congenital heart disease. Circulation. 2012 Oct 16;126(16):1944-54.
Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2012;60(14):1297-1313.

Responsible Party: Pocono Medical Center
ClinicalTrials.gov Identifier: NCT01948206     History of Changes
Other Study ID Numbers: PMC001
Study First Received: September 12, 2013
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 22, 2014