D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

February 11, 2008 updated by: Medtronic Cardiac Rhythm and Heart Failure
This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

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
    • Florida
      • Tampa, Florida, United States
    • Minnesota
      • Coon Rapids, Minnesota, United States
      • Rochester, Minnesota, United States
      • St. Paul, Minnesota, United States
    • North Carolina
      • Charlotte, North Carolina, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
  • Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement.

Exclusion Criteria:

  • Patients who have 3rd degree heart block, as assessed by the investigator
  • Patients who have a mechanical tricuspid heart valve
  • Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ventricular fibrillation (VF) detection time
Ventricular Capture Management accuracy

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

Investigators

  • Study Director: Cole Hannon, Medtronic CRDM

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

May 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

May 19, 2006

First Submitted That Met QC Criteria

May 19, 2006

First Posted (Estimate)

May 22, 2006

Study Record Updates

Last Update Posted (Estimate)

February 13, 2008

Last Update Submitted That Met QC Criteria

February 11, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 209

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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