Clinical Investigation of the Medtronic Concerto™ Device

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

Clinical Investigation of the Medtronic Concerto™ Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) Therapies (CRT+ICD Device)

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be prescribed.

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).

Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart. People with AT may experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness.

The purpose of this study is to study an investigational implantable device containing Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) therapies (CRT+ICD device) in subjects who are at significant risk of developing atrial tachyarrhythmias.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

270

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
      • Linz, Austria
      • St. Poelten, Austria
  • Denmark
      • Copenhagen, Denmark
  • Germany
      • Aachen, Germany
      • Bernau, Germany
      • Bochum, Germany
      • Goettingen, Germany
      • Heidelberg, Germany
      • Muenster, Germany
  • Greece
      • Patras, Greece
  • Italy
      • Bologna, Italy
    • Veneto
      • Negrar, Veneto, Italy
  • Japan
    • Ibaraki
      • Tsukuba, Ibaraki, Japan
    • Osaka
      • Suita, Osaka, Japan
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan
  • Netherlands
      • Eindhoven, Netherlands
      • Rotterdam, Netherlands
  • Norway
      • Oslo, Norway
  • Spain
      • Valencia, Spain
  • Switzerland
      • Basel, Switzerland
  • United Kingdom
      • Southhampton, United Kingdom
  • United States
    • Alaska
      • Anchorage, Alaska, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Santa Monica, California, United States
    • Florida
      • Jacksonville, Florida, United States
      • Orlando, Florida, United States
      • Pensacola, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Evanston, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Massachusetts
      • Brighton, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • Minnesota
      • St. Paul, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
      • St. Louis, Missouri, United States
    • New Jersey
      • Newark, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Syracuse, New York, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Fort Worth, Texas, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Tacoma, Washington, United States
    • West Virginia
      • Morgantown, West Virginia, 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 who require the implantation of an Implantable Cardioverter Defibrillator
  • Subjects who have heart failure that severely limits daily activities (NYHA Class III) or Subjects who have severe heart failure and should always be resting (NYHA Class IV)
  • Subjects with reduced heart pumping function (left ventricular ejection fraction ≤ 35%)

Exclusion Criteria:

  • Subjects who have constant atrial fibrillation (top chambers of the heart beat too fast continuously)
  • Subjects who are post-heart transplant

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
Complication rate
Atrial defibrillation effectiveness

Secondary Outcome Measures

Outcome Measure
Adverse events
Change in patient health status during the study
System performance

Collaborators and Investigators

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Not Required For IDE Studies

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

January 1, 2006

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

December 21, 2005

First Submitted That Met QC Criteria

December 21, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 25, 2008

Last Update Submitted That Met QC Criteria

September 22, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230

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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