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

This study is currently recruiting participants.

Verified by St. Jude Medical, April 2007

First Received: September 10, 2005 Last Updated: April 25, 2007 History of Changes

Sponsors and Collaborators:	St. Jude Medical Population Health Research Institute
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00256152

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation High Blood Pressure

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	2500
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both

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

Contacts

Contact: Ellison Themeles	905-527-4322 ext 44713	ellison@phri.ca
Contact: Erica Nunes	905-527-4322 ext 44522	erica@phri.ca

Locations

Canada, Ontario
McMaster University	Recruiting
Hamilton, Ontario, Canada
Contact: Stuart Connolly, MD 905-527-4322 ext 44563 connostu@hhsc.ca
Principal Investigator: Stuart Connolly, MD

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	University of Hong Kong
Principal Investigator:	Alessandro Capucci, MD	Ospedale Clinic, Piacenza Italy

More Information

No publications provided

Study ID Numbers:	CRD291
Study First Received:	September 10, 2005
Last Updated:	April 25, 2007
ClinicalTrials.gov Identifier:	NCT00256152 History of Changes
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

Study placed in the following topic categories:

Heart Diseases
Cerebral Infarction
Stroke
Vascular Diseases

Atrial Fibrillation
Arrhythmias, Cardiac
Hypertension

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Vascular Diseases
Cardiovascular Diseases

Atrial Fibrillation
Arrhythmias, Cardiac
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009