Clinical trial NCT00268320: Clinical Investigation of the Medtronic Concerto™ Device
Official title: Clinical Investigation of the Medtronic Concerto™ Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) Therapies (CRT+ICD Device)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
Keywords: congestive heart failure, atrial arrhythmia, cardiac resynchronization therapy, implantable cardioverter defibrillator
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2005-12-22
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Complication rate
measure: Atrial defibrillation effectiveness
Secondary outcomes:
measure: Change in patient health status during the study
measure: System performance
measure: Adverse events
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Santa Monica
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Evanston
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Brighton
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: St. Paul
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Newark
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Syracuse
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Pittsburgh
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Linz
country: Austria
city: St. Poelten
country: Austria
city: Copenhagen
country: Denmark
city: Aachen
country: Germany
city: Bernau
country: Germany
city: Bochum
country: Germany
city: Goettingen
country: Germany
city: Heidelberg
country: Germany
city: Muenster
country: Germany
city: Patras
country: Greece
city: Negrar
country: Italy
state: Veneto
city: Bologna
country: Italy
city: Tsukuba
country: Japan
state: Ibaraki
city: Suita
country: Japan
state: Osaka
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Eindhoven
country: Netherlands
city: Rotterdam
country: Netherlands
city: Oslo
country: Norway
city: Valencia
country: Spain
city: Basel
country: Switzerland
city: Southhampton
country: United Kingdom
Study officials:
name: Not required for IDE studies
References: