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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.
ClinicalTrials.gov Identifier: NCT00269230
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : November 20, 2008
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

December 21, 2005
December 23, 2005
November 20, 2008
July 2004
July 2005   (Final data collection date for primary outcome measure)
Safety and Efficacy at 3 months [ Time Frame: 3 Months ]
Safety and Efficacy at 3 months
Complete list of historical versions of study NCT00269230 on ClinicalTrials.gov Archive Site
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 ]
Implant success rate and times with the Model 4195; Handling characteristics and electrical performance of the Model 4195; All adverse events occurring throughout study
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Not Provided
 
Attain StarFix™ Model 4195 Left Ventricular Lead
Attain StarFix™ Model 4195 Left Ventricular Lead

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.

Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Heart Failure
Device: Pacing Lead
Left ventricular pacing lead
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
441
300
July 2005
July 2005   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Italy,   United States
 
 
NCT00269230
234
No
Not Provided
Not Provided
CRDM Core Clinical, Medtronic CRDM
Medtronic Cardiac Rhythm and Heart Failure
Not Provided
Principal Investigator: Stuart W Adler II, MD St. Paul Heart Clinic
Medtronic Cardiac Rhythm and Heart Failure
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP