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Optimal EGM Configuration for Morphology Discrimination (SVT Morphology)

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ClinicalTrials.gov Identifier: NCT00888667
Recruitment Status : Terminated (Patient population was not available)
First Posted : April 27, 2009
Last Update Posted : June 10, 2013
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:

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 or disease Intervention/treatment
Premature Ventricular Complexes Other: Pacing interventions

Study Type : Observational
Actual Enrollment : 3 participants
Time Perspective: Prospective
Official Title: Optimal EGM Configuration for Morphology Discrimination
Study Start Date : April 2009
Primary Completion Date : December 2009
Study Completion Date : May 2010

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. % morphology match [ Time Frame: acute ]
    off line analysis



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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:   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.

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 ClinicalTrials.gov identifier (NCT number): NCT00888667


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

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00888667     History of Changes
Other Study ID Numbers: HV001
First Posted: April 27, 2009    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: June 2013

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

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