Clinical Investigation of the Medtronic Concerto™ Device

Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268320
• Other study ID #: 230
• Status: Completed
• Phase: N/A
• First received: December 21, 2005
• Last updated: September 22, 2008
• Start date: January 2006
• Est. completion date: July 2007

Study information

• Verified date: September 2008
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines AgencyJapan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Austria,  Denmark,  Germany,  Greece,  Italy,  Japan,  Netherlands,  Norway,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate
Primary	Atrial defibrillation effectiveness
Secondary	Change in patient health status during the study
Secondary	System performance
Secondary	Adverse events