Clinical Investigation of the Medtronic Concerto™ Device

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00268320
First received: December 21, 2005
Last updated: September 22, 2008
Last verified: September 2008
  Purpose

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 Intervention
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
Device: Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Complication rate
  • Atrial defibrillation effectiveness

Secondary Outcome Measures:
  • Change in patient health status during the study
  • System performance
  • Adverse events

Estimated Enrollment: 270
Study Start Date: January 2006
Study Completion Date: July 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268320

  Show 51 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Investigator: Not required for IDE studies
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00268320     History of Changes
Other Study ID Numbers: 230
Study First Received: December 21, 2005
Last Updated: September 22, 2008
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Japan: Ministry of Health, Labor and Welfare

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
congestive heart failure, atrial arrhythmia, cardiac resynchronization therapy, implantable cardioverter defibrillator

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

ClinicalTrials.gov processed this record on October 21, 2014