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OpenTrials
Completed

NCT Number: NCT00268320

Clinical Investigation of the Medtronic Concerto™ Device

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.

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Key information

Conditions

Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator

Device

Primary outcomes

  1. Complication rate

  2. Atrial defibrillation effectiveness

Secondary outcomes

  1. Change in patient health status during the study

  2. System performance

  3. Adverse events

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Dec 22, 2005
Registry last updated
Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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