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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: CRM Device

• Registration Number: NCT00837798
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5379

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No history of AF	CRM Device	Patient should not have had a documented history of AF for a period of 3 months prior to enrollment.

Primary Outcome Measures

Name	Time	Method
Prevalence of atrial tachycardia and atrial fibrillation in a cardiac rhythm management population	24 months

Secondary Outcome Measures

Name	Time	Method
Development or exacerbation of HF	2 years
Development of AF	2 years
AT/AF burden	2 years

Trial Locations

Locations (1)

St Jude Medical; 🇺🇸 Sylmar, California, United States