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
  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 ] [ 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
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: 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 August 28, 2014