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
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||441 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Device: Pacing Lead
Left ventricular pacing lead
- Safety and Efficacy at 3 months [ Time Frame: 3 Months ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00269230
Show 25 Study Locations
|Principal Investigator:||Stuart W Adler II, MD||St. Paul Heart Clinic|