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RATE Registry - Registry of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) Episodes in the Cardiac Rhythm Management (CRM) Device Population (RATE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837798
First Posted: February 5, 2009
Last Update Posted: December 20, 2012
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.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
The purpose of this registry is to produce a prospective, outcome-oriented registry to document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF Diagnostics in select SJM devices.

Condition Intervention
Atrial Fibrillation Device: CRM Device

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Registry of AT/AF Episodes in the CRM Device Population: RATE Registry

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Prevalence of atrial tachycardia and atrial fibrillation in a cardiac rhythm management population [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Development or exacerbation of HF [ Time Frame: 2 years ]
  • Development of AF [ Time Frame: 2 years ]
  • AT/AF burden [ Time Frame: 2 years ]

Enrollment: 5379
Study Start Date: October 2006
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No history of AF
Patient should not have had a documented history of AF for a period of 3 months prior to enrollment.
Device: CRM Device
Pacemaker, ICD, or CRT device

  Eligibility

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
Patients with a CRM device
Criteria

Inclusion Criteria:

  • Patient is implanted with a CRM device
  • Patient has no documented history of AF (3 months prior to enrollment)
  • Patient is >18 years of age
  • Patient has life expectancy of >24 months
  Contacts and Locations
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): NCT00837798


Locations
United States, California
St Jude Medical
Sylmar, California, United States, 91342
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Chair: Albert Waldo, MD University Hospitals Cleveland Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00837798     History of Changes
Other Study ID Numbers: 374
First Submitted: February 4, 2009
First Posted: February 5, 2009
Last Update Posted: December 20, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes