NCT00837798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,379

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

5.5 years

First QC Date

February 4, 2009

Last Update Submit

February 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of atrial tachycardia and atrial fibrillation in a cardiac rhythm management population

    24 months

Secondary Outcomes (3)

  • Development or exacerbation of HF

    2 years

  • Development of AF

    2 years

  • AT/AF burden

    2 years

Study Arms (1)

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

Interventions

Pacemaker, ICD, or CRT device

No history of AF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a CRM device

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Jude Medical

Sylmar, California, 91342, United States

Location

Related Publications (2)

  • Orlov MV, Olshansky B, Benditt DG, Kotler G, McIntyre T, Fujian Qu, Turkel M, Gorev M, Poghosyan H, Waldo AL. Is competitive atrial pacing a possible trigger for atrial fibrillation? Observations from the RATE registry. Heart Rhythm. 2021 Jan;18(1):3-9. doi: 10.1016/j.hrthm.2020.07.028. Epub 2020 Jul 30.

  • Swiryn S, Orlov MV, Benditt DG, DiMarco JP, Lloyd-Jones DM, Karst E, Qu F, Slawsky MT, Turkel M, Waldo AL; RATE Registry Investigators. Clinical Implications of Brief Device-Detected Atrial Tachyarrhythmias in a Cardiac Rhythm Management Device Population: Results from the Registry of Atrial Tachycardia and Atrial Fibrillation Episodes. Circulation. 2016 Oct 18;134(16):1130-1140. doi: 10.1161/CIRCULATIONAHA.115.020252.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Albert Waldo, MD

    University Hospitals Cleveland Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

October 1, 2006

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations