Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

This study has been completed.

Sponsor:

Collaborator:

Population Health Research Institute

Information provided by (Responsible Party):

St. Jude Medical

ClinicalTrials.gov Identifier:

NCT00256152

First received: September 10, 2005

Last updated: July 27, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 10, 2005

Last Updated Date

July 27, 2012

Start Date ^ICMJE

September 2004

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Composite of ischemic stroke & Non-CNS systemic embolism [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Symptomatic or Asymptomatic AT documented by ECG [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Ischemic stroke, Non-CNS systemic embolism
Primary study outcome will be a composite of:

Change History

Complete list of historical versions of study NCT00256152 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Clinical documented atrial fibrillation or flutter
Myocardial infarction [MI], Vascular death Composite of stroke, MI or vascular death

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

Official Title ^ICMJE

Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

Brief Summary

In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.

Overdrive atrial pacing with the AF Suppression algorithm will reduce the risk of symptomatic AF in patients with standard indication for pacing and no previous history of AF.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension
Atrial Fibrillation

Intervention ^ICMJE

Device: AF Suppression Pacing Algorithm

Study Arm (s)

No Intervention: AF Suppression OFF
Experimental: AF Suppression ON
Intervention: Device: AF Suppression Pacing Algorithm

Publications *

Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2580

Completion Date

June 2010

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

Age ≥ 65 years
History of hypertension requiring pharmacological therapy (≥ 4 weeks of therapy).
Recent (< 8 weeks) St. Jude Medical Inc. pacemaker implant (IDENTITY® Adx DR (Model 5386/5380)), ICD implant (EPIC 2 or Atlas 2) or other St. Jude Medical Inc. pacemaker or ICD with the same capabilities.
In pacemaker patients only the primary indication for pacing is sinus or AV node disease.

Exclusion Criteria

Previous documented AF, atrial flutter (lasting greater than 5 minutes), or other sustained SVT (not including episodes detected by the device)
Geographic/social or psychiatric factor likely to interfere with follow-up
Requirement for oral anticoagulation (heart valve, deep vein thrombosis, etc.)

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00256152

Other Study ID Numbers ^ICMJE

CRD291

Has Data Monitoring Committee

Responsible Party

St. Jude Medical

Study Sponsor ^ICMJE

St. Jude Medical

Collaborators ^ICMJE

Population Health Research Institute

Investigators ^ICMJE

Study Chair:	Stuart Connolly, MD	McMaster University
Study Chair:	Stephan Hohnloser, MD	Goethe University
Principal Investigator:	Carlos Morillo, MD	McMaster University
Principal Investigator:	Jeff Healey, MD	McMaster University
Principal Investigator:	Carsten Israel, MD	Goethe University
Principal Investigator:	Michael Gold, MD	Medical University of South Carolina
Principal Investigator:	Chu-Pak Lau, MD	The University of Hong Kong
Principal Investigator:	Alessandro Capucci, MD	Ospedale Clinic, Piacenza Italy

Information Provided By

St. Jude Medical

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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