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

Purpose

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.

Condition	Intervention	Phase
Hypertension Atrial Fibrillation	Device: AF Suppression Pacing Algorithm	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation High Blood Pressure

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	2580
Study Start Date:	September 2004
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: AF Suppression OFF
Experimental: AF Suppression ON	Device: AF Suppression Pacing Algorithm

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256152

Locations

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada

Sponsors and Collaborators

St. Jude Medical

Population Health Research Institute

Investigators

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

More Information

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lau CP, Gbadebo TD, Connolly SJ, Van Gelder IC, Capucci A, Gold MR, Israel CW, Morillo CA, Siu CW, Abe H, Carlson M, Tse HF, Hohnloser SH, Healey JS; ASSERT investigators. Ethnic differences in atrial fibrillation identified using implanted cardiac devices. J Cardiovasc Electrophysiol. 2013 Apr;24(4):381-7. doi: 10.1111/jce.12066. Epub 2013 Jan 28.

Hohnloser SH, Healey JS, Gold MR, Israel CW, Yang S, van Gelder I, Capucci A, Lau CP, Fain E, Morillo CA, Ha A, Carlson M, Connolly SJ; ASSERT Investigators. Atrial overdrive pacing to prevent atrial fibrillation: insights from ASSERT. Heart Rhythm. 2012 Oct;9(10):1667-73. doi: 10.1016/j.hrthm.2012.06.012. Epub 2012 Jun 12.

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.

Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00256152 History of Changes
Other Study ID Numbers:	CRD291
Study First Received:	September 10, 2005
Last Updated:	July 27, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Medical:

Atrial fibrillation
Pacemaker
AF suppression pacing
Indications for Pacemaker Implantation due to sinus node or atrio-ventricular node disease

Additional relevant MeSH terms:

Atrial Fibrillation
Hypertension
Arrhythmias, Cardiac
Heart Diseases

Cardiovascular Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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