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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00837798
First received: February 4, 2009
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development or exacerbation of HF [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Development of AF [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • AT/AF burden [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00837798     History of Changes
Other Study ID Numbers: 374
Study First Received: February 4, 2009
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013