The Atrial High Rate Episodes in Pacemaker Patients

February 22, 2008 updated by: Medtronic Cardiac Rhythm and Heart Failure

The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

427

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Ashford, Australia
      • Ballarat, Australia
      • Bedford Park, Australia
  • France
      • Lille, France
      • Rouen, France
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Fresno, California, United States
      • Glendale, California, United States
      • San Diego, California, United States
    • Florida
      • Daytona Beach, Florida, United States
      • Orlando, Florida, United States
    • Indiana
      • Hammond, Indiana, United States
      • Hobart, Indiana, United States
      • Munster, Indiana, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • Marrero, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Salisbury, Maryland, United States
    • Massachusetts
      • West Roxbury, Massachusetts, United States
    • Minnesota
      • St. Cloud, Minnesota, United States
    • New Jersey
      • Livingston, New Jersey, United States
      • Patterson, New Jersey, United States
    • New York
      • Bronx,, New York, United States
      • Flushing, New York, United States
      • Rochester, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Gastonia, North Carolina, United States
      • Greenville, North Carolina, United States
      • Willimington, North Carolina, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Mechanicsburg, Pennsylvania, United States
      • Scranton, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
    • Virginia
      • Falls Church, Virginia, United States
      • Richmond, Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
pacemaker patients with previously diagnosed AT.
2
pacemaker patients without previously diagnosed AT.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: M. V. Orlov, MD, Tufts University School of Medicine
  • Principal Investigator: J.K. Ghali, MD, Louisiana State University Health Sciences Center in New Orleans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Study Completion (ACTUAL)

September 1, 2004

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

February 22, 2008

First Posted (ESTIMATE)

March 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2008

Last Update Submitted That Met QC Criteria

February 22, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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