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Attain StarFix™ Model 4195 Left Ventricular Lead

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00269230
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : November 20, 2008
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:

People who have abnormal heart beats, or whose heart does not beat on its own, may need an electronic device called a pacemaker or a defibrillator. Furthermore, people whose hearts have a reduced pumping ability may need a device are called cardiac resynchronization therapy (CRT) device. A CRT device is implanted surgically just under the skin in the upper chest area. This device then helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The device may also be able to stop the heart from beating too fast. Three leads are implanted into the chambers of your heart. Two of the leads will be placed on the right side of your heart. The third lead is placed on the left side of your heart and is the lead being studied.

The purpose of this study is to evaluate the safety and efficacy of the Attain StarFixTM Model 4195 Left Ventricular (LV) Lead. This particular model lead has special characteristics that may help to better keep it in position once it is implanted into the left ventricle. It is also "steroid-eluting" which means that over time it slowly releases a small amount of medication into the heart tissue to help prevent too much swelling around the area it is implanted.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Pacing Lead Not Applicable

Expanded Access : Medtronic Cardiac Rhythm and Heart Failure has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 441 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Attain StarFix™ Model 4195 Left Ventricular Lead
Study Start Date : July 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Intervention Details:
  • Device: Pacing Lead
    Left ventricular pacing lead

Primary Outcome Measures :
  1. Safety and Efficacy at 3 months [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. Implant success rate and times with the Model 4195; Handling characteristics and electrical performance of the Model 4195; All adverse events occurring throughout study [ Time Frame: Ongoing ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • QRS > 130 ms (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. A wide QRS (more than 120) suggests that there is a conduction problem, or block, in the ventricles.)
  • Left Ventricular Ejection Fraction (EF) < 35% (Ejection Fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the EF the more blood the ventricle is pumping.)
  • Subject has moderate to severe heart failure despite medications

Exclusion Criteria:

  • Subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt
  • Subjects with chest pain or who have had a heart attack within the past month before enrollment in the study
  • Subjects that have had certain surgeries on their heart within the past three months
  • Subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00269230

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United States, California
Long Beach, California, United States
Palo Alto, California, United States
United States, Delaware
Newark, Delaware, United States
United States, Florida
Jacksonville, Florida, United States
Orlando, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Michigan
Grand Rapids, Michigan, United States
Saginaw, Michigan, United States
United States, Minnesota
St. Paul, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, New Jersey
Newark, New Jersey, United States
United States, New York
Rochester, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Tennessee
Germantown, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Temple, Texas, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Canada, Alberta
Calgary, Alberta, Canada
Canada, British Columbia
Victoria, British Columbia, Canada
Canada, Ontario
London, Ontario, Canada
Canada, Quebec
Sainte-Foy, Quebec, Canada
Milano, Italy
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
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Principal Investigator: Stuart W Adler II, MD St. Paul Heart Clinic
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Responsible Party: CRDM Core Clinical, Medtronic CRDM Identifier: NCT00269230    
Other Study ID Numbers: 234
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: November 20, 2008
Last Verified: October 2008
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
cardiac resynchronization therapy, left ventricular Lead, Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases