The Atrial High Rate Episodes in Pacemaker Patients

NCT ID: NCT00627328

Last Updated: 2008-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

427 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-07-31

Study Completion Date

2004-09-30

Brief Summary

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Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.

Detailed Description

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The purpose of this study is to assess the incidence of fast heart rates that originate in the upper chamber of the heart (atrial tachyarrhythmias) in pacemaker patients that have not been previously diagnosed with this condition. The study will also look at how the diagnostic feature in the pacemaker that detects atrial tachyarrhythmias helps physicians with the medical management of patients' heart rhythm.

Conditions

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Arrhythmia Atrial Fibrillation Atrioventricular Block Bradycardia Sick Sinus Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

pacemaker patients with previously diagnosed AT.

No interventions assigned to this group

2

pacemaker patients without previously diagnosed AT.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications
* No previous history of pacemaker implantation
* Patients 50 years of age or older

Exclusion Criteria

* Patients with a history of atrial tachyarrhythmias (primary arm of study)
* Patients with medical conditions that would limit study participation
* Patients inaccessible for follow-up at the study center
* Patients incapable of providing Informed Consent
* Patients with NYHA classification of IV
* Patients with a history of neurocardiogenic syncope, long QT syndrome, or Hypertrophic Obstructive Cardiomyopathy (HOCM)
* Patients taking Sotalol or Amiodorone
* Patients with a history of a prior ICD or pacemaker implantation.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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CRDM Clincial Research

Principal Investigators

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M. V. Orlov, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Medicine

J.K. Ghali, MD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Sciences Center in New Orleans

Locations

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Fresno, California, United States

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Glendale, California, United States

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San Diego, California, United States

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Daytona Beach, Florida, United States

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Orlando, Florida, United States

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Hammond, Indiana, United States

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Hobart, Indiana, United States

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Munster, Indiana, United States

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Louisville, Kentucky, United States

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Marrero, Louisiana, United States

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Shreveport, Louisiana, United States

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Salisbury, Maryland, United States

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West Roxbury, Massachusetts, United States

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Saint Cloud, Minnesota, United States

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Livingston, New Jersey, United States

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Patterson, New Jersey, United States

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Flushing, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Gastonia, North Carolina, United States

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Greenville, North Carolina, United States

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Willimington, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Bethlehem, Pennsylvania, United States

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Mechanicsburg, Pennsylvania, United States

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Scranton, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Providence, Rhode Island, United States

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Chattanooga, Tennessee, United States

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Dallas, Texas, United States

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Falls Church, Virginia, United States

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Richmond, Virginia, United States

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Milwaukee, Wisconsin, United States

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Ashford, , Australia

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Ballarat, , Australia

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Bedford Park, , Australia

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Lille, , France

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Rouen, , France

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Countries

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United States Australia France

References

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Ghali JK, Orlov MV, Araghi-Niknam M, Sherfesee L, Hettrick DA. The influence of symptoms and device detected atrial tachyarrhythmias on medical management: insights from A-HIRATE. Pacing Clin Electrophysiol. 2007 Jul;30(7):850-7. doi: 10.1111/j.1540-8159.2007.00772.x.

Reference Type BACKGROUND
PMID: 17584266 (View on PubMed)

Orlov MV, Ghali JK, Araghi-Niknam M, Sherfesee L, Sahr D, Hettrick DA; Atrial High Rate Trial Investigators. Asymptomatic atrial fibrillation in pacemaker recipients: incidence, progression, and determinants based on the atrial high rate trial. Pacing Clin Electrophysiol. 2007 Mar;30(3):404-11. doi: 10.1111/j.1540-8159.2007.00682.x.

Reference Type RESULT
PMID: 17367361 (View on PubMed)

Other Identifiers

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163

Identifier Type: -

Identifier Source: org_study_id

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