Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG

October 11, 2006 updated by: Medtronic Cardiac Rhythm and Heart Failure

People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm.

The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device. A feature of this device allows it to send small, painless electrical impulses (Anti-tachycardia pacing or ATP) to the heart instead of shocking it out of a rhythm that is too fast. Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock to the heart can feel like a punch in the chest. This device also allows the heart to beat on its own when it can and helping it (by pacing, or sending it electrical signals) when it needs help. This feature is important because previously studies have shown that pacing the heart too often can increase the risk for heart failure or for atrial fibrillation (having too rapid of heart beats in the atrium).

This study is now complete and the device has since been approved by the FDA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

500

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

  • Austria
      • St. Poelten, Austria
      • Steyr, Austria
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Kingston, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Sainte-Foy, Quebec, Canada
  • Denmark
      • Copenhagen, Denmark
  • Germany
      • Bonn, Germany
      • Goettingen, Germany
      • Heidelberg, Germany
      • Kaiserslautern, Germany
      • Muenchen, Germany
      • Muenster, Germany
  • Netherlands
      • Eindhoven, Netherlands
  • Switzerland
      • Basel, Switzerland
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Glendale, California, United States
      • Inglewood, California, United States
    • Florida
      • Atlantis, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Macon, Georgia, United States
    • Indiana
      • Ft. Wayne, Indiana, United States
    • Iowa
      • Davenport, Iowa, United States
      • Des Moines, Iowa, United States
    • Maryland
      • Salisbury, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Missouri
      • Kansas City, Missouri, United States
      • St. Louis, Missouri, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Austin, Texas, United States
      • Dallas, Texas, United States
    • Virginia
      • Richmond, Virginia, United States
    • West Virginia
      • Morgantown, West 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects with failure but no symptoms (NYHA Class I) or subjects with mild heart failure that only sometimes interferes with daily activities (NYHA Class II)

Subjects who have, or are risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD)

Subjects who have, or are at risk of developing, rapid beats in the upper chambers of the heart (atrial tachyarrhythmias)

Exclusion Criteria:

Subjects with rapid heart beats in their ventricles (lower chambers of the heart) associated only with reversible causes

Subjects with mechanical tricuspid heart valves (A structure in the heart, located between the right atrium and right ventricle, which allows blood to flow down from the atrium into the ventricle.)

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
Safety and efficacy at three months.

Secondary Outcome Measures

Outcome Measure
To evaluate how well the device distinguished between arrhythmias originating in the atrium versus those that originate in the ventricle.
To evaluate how well the anti-tachycardia pacing function works.
To observe the overall performance of the device system.

Collaborators and Investigators

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

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

April 1, 2004

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

January 4, 2006

First Submitted That Met QC Criteria

January 4, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

October 13, 2006

Last Update Submitted That Met QC Criteria

October 11, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213

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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