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

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

Primary Outcomes: Complication rate; Atrial defibrillation effectiveness
Secondary Outcomes: Change in patient health status during the study; System performance; Adverse events
Expected Total Enrollment:  430

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00268320

Medtronic CRM Clinical Trials       medtroniccrmclinicaltrials.com

Alaska
      Anchorage,  Alaska,  United States
Arizona
      Phoenix,  Arizona,  United States
California
      Santa Monica,  California,  United States
Florida
      Pensacola,  Florida,  United States
      Orlando,  Florida,  United States
      Jacksonville,  Florida,  United States
Georgia
      Atlanta,  Georgia,  United States
Illinois
      Evanston,  Illinois,  United States
Indiana
      Fort Wayne,  Indiana,  United States
Iowa
      Des Moines,  Iowa,  United States
Massachusetts
      Brighton,  Massachusetts,  United States
Michigan
      Detroit,  Michigan,  United States
Minnesota
      St. Paul,  Minnesota,  United States
Missouri
      St. Louis,  Missouri,  United States
      Kansas City,  Missouri,  United States
New Jersey
      Newark,  New Jersey,  United States
New Mexico
      Albuquerque,  New Mexico,  United States
New York
      Syracuse,  New York,  United States
Ohio
      Cincinnati,  Ohio,  United States
      Cleveland,  Ohio,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  United States
Pennsylvania
      West Reading,  Pennsylvania,  United States
      Pittsburgh,  Pennsylvania,  United States
South Carolina
      Charleston,  South Carolina,  United States
Tennessee
      Nashville,  Tennessee,  United States
Texas
      Fort Worth,  Texas,  United States
      Austin,  Texas,  United States
Virginia
      Richmond,  Virginia,  United States
Washington
      Tacoma,  Washington,  United States
West Virginia
      Morgantown,  West Virginia,  United States
Austria
      St. Poelten,  Austria
      Linz,  Austria
Denmark
      Copenhagen,  Denmark
Germany
      Bochum,  Germany
      Bernau,  Germany
      Aachen,  Germany
      Muenster,  Germany
      Heidelberg,  Germany
      Goettingen,  Germany
Greece
      Patras,  Greece
Italy
      Bologna,  Italy
Italy, Veneto
      Negrar,  Veneto,  Italy
Japan, Ibaraki
      Tsukuba,  Ibaraki,  Japan
Japan, Osaka
      Suita,  Osaka,  Japan
Japan, Tokyo
      Shinjuku-ku,  Tokyo,  Japan
Netherlands
      Eindhoven,  Netherlands
      Rotterdam,  Netherlands
Norway
      Oslo,  Norway
Spain
      Valencia,  Spain
Switzerland
      Basel,  Switzerland
United Kingdom
      Southhampton,  United Kingdom

Study chairs or principal investigators

Not required for IDE studies

Study ID Numbers:  230
Last Updated:  December 21, 2005
Record first received:  December 21, 2005
ClinicalTrials.gov Identifier:  NCT00268320
Health Authority: United States: Food and Drug Administration; European Union: European Medicines Agency; Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2006-01-10