VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies

March 26, 2007 updated by: Medtronic Cardiac Rhythm and Heart Failure
The purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this registry is to gain a better understanding of how diagnostic capabilities in four Vitatron pacemakers (Selection AFm, Clarity, C-Series, and T-Series) are being utilized for the clinical management of a general pacing population. Pacemaker information and health status is collected from all patients enrolled.

Study Type

Observational

Enrollment

950

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

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Little Rock, Arkansas, United States
      • North Little Rock, Arkansas, United States
    • Florida
      • Ft. Lauderdale, Florida, United States
      • Largo, Florida, United States
      • Ormond Beach, Florida, United States
      • St. Petersburg, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kentucky
      • Edgewood, Kentucky, United States
      • Louisville, Kentucky, United States
    • Massachusetts
      • Hyannis, Massachusetts, United States
    • Michigan
      • Lansing, Michigan, United States
    • New York
      • Bay Shore, New York, United States
      • Syracuse, New York, United States
    • North Dakota
      • Bismark, North Dakota, United States
    • Ohio
      • Barberton, Ohio, United States
      • Cincinnati, Ohio, United States
      • Marion, Ohio, United States
      • Massillon, Ohio, United States
      • Middletown, Ohio, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Texas
      • Arlington, Texas, United States
      • Austin, Texas, United States
      • Beaumont, Texas, United States
      • McKinney, Texas, United States
    • Wisconsin
      • Waukesha, 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Class I or Class II indication for dual chamber pacing

Exclusion Criteria:

  • Has an ICD or is a known candidate for an ICD

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

  • Observational Models: Defined Population
  • Time Perspectives: Prospective

Collaborators and Investigators

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic
Medtronic BRC

Investigators

  • Principal Investigator: Norman Jaffe, MD, Onondaga Hill Cardiovascular Group
  • Principal Investigator: Luis Caceres, MD, Prairie Cardiovascular Consultants

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

October 1, 2002

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (Estimate)

February 20, 2006

Study Record Updates

Last Update Posted (Estimate)

March 27, 2007

Last Update Submitted That Met QC Criteria

March 26, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 197

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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