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

Atrial Fibrillation Clinical Trial

— RATE  

Official title:

Registry of AT/AF Episodes in the CRM Device Population: RATE Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837798
• Other study ID #: 374
• Status: Completed
• Start date: October 2006
• Est. completion date: April 2012

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5379
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• CRM Device
Pacemaker, ICD, or CRT device

Locations

Country	Name	City	State
United States	St Jude Medical	Sylmar	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of atrial tachycardia and atrial fibrillation in a cardiac rhythm management population		24 months
Secondary	Development or exacerbation of HF		2 years
Secondary	Development of AF		2 years
Secondary	AT/AF burden		2 years