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NCT00269230 · ClinicalTrials.gov registry record · NA
Attain StarFix™ Model 4195 Left Ventricular Lead
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 441
- Enrollment target
NCT00269230 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 441 participants.
The verdict
NCT00269230, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 441 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Pacing Lead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 441 participants |
| Start Date | 2004-07 |
| Est. Completion | 2005-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00269230
The ClinicalTrials.gov registry entry for NCT00269230 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 441 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pacing Lead is the first listed.
NCT00269230 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00269230 about?
NCT00269230 is a clinical study titled "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 devic...
What is the current status of trial NCT00269230?
This trial is currently completed. It is a NA study. The enrollment target is 441 participants. The study started on 2004-07. Estimated completion is 2005-07.
What interventions are being tested in trial NCT00269230?
The interventions under investigation include: Pacing Lead (DEVICE).
Who is sponsoring clinical trial NCT00269230?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
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