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Clinical Investigation of the Medtronic Concerto™ Device

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ClinicalTrials.gov Identifier: NCT00268320
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : September 25, 2008
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation Device: Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 270 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the Medtronic Concerto™ Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) Therapies (CRT+ICD Device)
Study Start Date : January 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Complication rate
  2. Atrial defibrillation effectiveness

Secondary Outcome Measures :
  1. Change in patient health status during the study
  2. System performance
  3. Adverse events


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268320


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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
OverallOfficial: Not required for IDE studies

ClinicalTrials.gov Identifier: NCT00268320     History of Changes
Other Study ID Numbers: 230
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2008

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
congestive heart failure, atrial arrhythmia, cardiac resynchronization therapy, implantable cardioverter defibrillator

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Tachycardia
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes