Optimal EGM Configuration for Morphology Discrimination (SVT Morphology)

This study has been terminated.
(Patient population was not available)
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00888667
First received: April 24, 2009
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

The study will be a prospective cohort study of 20 patients recruited from site's Defibrillator Clinic patient population who are followed at the site.

Hypothesis: Among the available EGM configuration options, one is better than the others for detection enhancements purposes.


Condition Intervention
Premature Ventricular Complexes
Other: Pacing interventions

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Optimal EGM Configuration for Morphology Discrimination

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • % morphology match [ Time Frame: acute ] [ Designated as safety issue: No ]
    off line analysis


Enrollment: 3
Study Start Date: April 2009
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ICD patient with frequent PVCs Other: Pacing interventions
10 seconds recording of atrial paced rhythm at 100 ppm in sitting 10 seconds recording of atrial paced rhythm at 150 ppm in supine 10 seconds recording of atrial paced rhythm at 150 ppm in sitting

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with a dual chamber ICD and frequent PVCs

Criteria

Inclusion Criteria:

  1. Patients must already have an implanted St. Jude Medical dual chamber ICD with a dual coil defibrillator lead.
  2. Patients must be willing to sign an informed consent form.
  3. Patients must have frequent PVCs (minimum of 30/hour)

Exclusion Criteria:

  1. Known history of slow VT (under 160 bpm).
  2. Patients under the age of 18 years.
  3. Pregnant women.
  4. Pacemaker dependent rhythm.
  5. Ongoing angina pectoris.
  6. Current NYHA Class 3-4 heart failure.
  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: NCT00888667

Locations
Canada, Ontario
St Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
St. Jude Medical
St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00888667     History of Changes
Other Study ID Numbers: HV001
Study First Received: April 24, 2009
Last Updated: June 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Jude Medical:
ICD patients with PVCs and EGM recordings

Additional relevant MeSH terms:
Ventricular Premature Complexes
Arrhythmias, Cardiac
Cardiac Complexes, Premature
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014