RATE Registry - Registry of Atrial Tachyarrhythmia/Atrial... | NCT00837798

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

NCT00837798

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

5,379Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

CRM Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Feb 4, 2009

First Submission Date that Met QC Criteria

Feb 4, 2009

First Posted Date

Feb 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,379Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CRM Device	Device	Pacemaker, ICD, or CRT device	No history of AF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of atrial tachycardia and atrial fibrillation in a cardiac rhythm management population		24 months

Secondary Outcomes

Measure	Description	Time Frame
Development or exacerbation of HF		2 years
Development of AF		2 years
AT/AF burden

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a CRM device

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Albert Waldo, MD	University Hospitals Cleveland Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Jude Medical		Sylmar	California	91342	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32738404	Derived	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.
27754946	Derived

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes