Clinical Investigation of the Medtronic Concerto™ Device - Full Text View

Sponsor:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00268320

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Heart Failure Pacemakers and Implantable Defibrillators

U.S. FDA Resources

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

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:

Arrhythmias, Cardiac
Atrial Fibrillation
Heart Failure
Tachycardia
Atrial Premature Complexes

Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Complexes, Premature

ClinicalTrials.gov processed this record on February 09, 2012