NCT00627328

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
427

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2000

Longer than P75 for all trials

Geographic Reach
3 countries

42 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
Last Updated

March 3, 2008

Status Verified

February 1, 2008

First QC Date

December 26, 2007

Last Update Submit

February 22, 2008

Conditions

Keywords

Physiologic PacingDual Chamber PacingAtrioventricular BlockBradycardiaSick Sinus Syndrome

Study Arms (2)

1

pacemaker patients with previously diagnosed AT.

2

pacemaker patients without previously diagnosed AT.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective study with patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Fresno, California, United States

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Unknown Facility

Glendale, California, United States

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Unknown Facility

San Diego, California, United States

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Unknown Facility

Daytona Beach, Florida, United States

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Unknown Facility

Orlando, Florida, United States

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Unknown Facility

Hammond, Indiana, United States

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Unknown Facility

Hobart, Indiana, United States

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Unknown Facility

Munster, Indiana, United States

Location

Unknown Facility

Louisville, Kentucky, United States

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Unknown Facility

Marrero, Louisiana, United States

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Unknown Facility

Shreveport, Louisiana, United States

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Unknown Facility

Salisbury, Maryland, United States

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Unknown Facility

West Roxbury, Massachusetts, United States

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Unknown Facility

Saint Cloud, Minnesota, United States

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Unknown Facility

Livingston, New Jersey, United States

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Unknown Facility

Patterson, New Jersey, United States

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Unknown Facility

Flushing, New York, United States

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Unknown Facility

Rochester, New York, United States

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Unknown Facility

Syracuse, New York, United States

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Unknown Facility

The Bronx, New York, United States

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Unknown Facility

Charlotte, North Carolina, United States

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Unknown Facility

Gastonia, North Carolina, United States

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Unknown Facility

Greenville, North Carolina, United States

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Unknown Facility

Willimington, North Carolina, United States

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Unknown Facility

Oklahoma City, Oklahoma, United States

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Unknown Facility

Bethlehem, Pennsylvania, United States

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Unknown Facility

Mechanicsburg, Pennsylvania, United States

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Unknown Facility

Scranton, Pennsylvania, United States

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Unknown Facility

Wynnewood, Pennsylvania, United States

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Unknown Facility

Providence, Rhode Island, United States

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Unknown Facility

Chattanooga, Tennessee, United States

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Unknown Facility

Dallas, Texas, United States

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Unknown Facility

Falls Church, Virginia, United States

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Unknown Facility

Richmond, Virginia, United States

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Unknown Facility

Milwaukee, Wisconsin, United States

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Unknown Facility

Ashford, Australia

Location

Unknown Facility

Ballarat, Australia

Location

Unknown Facility

Bedford Park, Australia

Location

Unknown Facility

Lille, France

Location

Unknown Facility

Rouen, France

Location

Related Publications (2)

  • 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.

    PMID: 17584266BACKGROUND
  • 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.

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial FibrillationAtrioventricular BlockBradycardiaSick Sinus Syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockCardiac Conduction System DiseaseArrhythmia, Sinus

Study Officials

  • M. V. Orlov, MD

    Tufts University School of Medicine

    PRINCIPAL INVESTIGATOR
  • J.K. Ghali, MD

    Louisiana State University Health Sciences Center in New Orleans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 26, 2007

First Posted

March 3, 2008

Study Start

July 1, 2000

Study Completion

September 1, 2004

Last Updated

March 3, 2008

Record last verified: 2008-02

Locations