Attain StarFix™ Model 4195 Left Ventricular Lead

NCT00269230 | Completed

• 1 other identifier: 234
• Study Type: interventional
• Target: 441
• Locations: 3 countries
• Sites: 25

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.

Conditions

Heart Failure

Keywords

cardiac resynchronization therapy, left ventricular Lead, Heart Failure

Outcome Measures

Primary Outcomes (1)

• Safety and Efficacy at 3 months

  3 Months

Secondary Outcomes (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

  Ongoing

Interventions

Pacing Lead DEVICE

Left ventricular pacing lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (25)

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Palo Alto, California, United States

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Newark, Delaware, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Lexington, Kentucky, United States

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Grand Rapids, Michigan, United States

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Saginaw, Michigan, United States

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Saint Paul, Minnesota, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Newark, New Jersey, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Temple, Texas, United States

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Milwaukee, Wisconsin, United States

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Calgary, Alberta, Canada

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Victoria, British Columbia, Canada

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London, Ontario, Canada

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Sainte-Foy, Quebec, Canada

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Unknown Facility

Milan, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Stuart W Adler II, MD

  St. Paul Heart Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 23, 2005
• Study Start: July 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: November 20, 2008

Record last verified: 2008-10

Locations

IT (1); CA (4); US (20)