EASYTRAK 4 Steerable LV Lead
This study has been completed.
Information provided by:
Boston Scientific Corporation
First received: September 8, 2005
Last updated: June 22, 2007
Last verified: June 2007
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
Device: EASYTRAK 4 STEERABLE LV lead
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||EASYTRAK® 4 STEERABLE LV Lead Clinical Investigation
Primary Outcome Measures:
- Lead-related complication free-rate at 3-months.
- Chronic mean pacing thresholds at 3-months.
Secondary Outcome Measures:
- Chronic Mean pacing impedances at 3-months
- Chronic Mean R-wave amplitudes at 3-months
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
This is a prospective, multi-center clinical study is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Must receive a commercially available Guidant CRT-P or CRT-D device
- Creatinine < 2.5 mg/dL obtained no more than two weeks prior to enrollment
- Age 18 or above, or of legal age to give informed consent specific to state and national law
- Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
- Geographically stable residents who are available for follow-up
- Have a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) nominal dose of dexamethasone acetate
- Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement
- Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
- Currently requiring dialysis
- Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
- Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
- Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
- Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study
- Have a pre-existing unipolar pacemaker that will not be explanted/abandoned
- Have a mechanical tricuspid heart valve
- Women who are pregnant or plan to become pregnant Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158964
|St.Paul, Minnesota, United States |
Boston Scientific Corporation
||Stephen Mester, MD
||Tampa General Hospital
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2005
||June 22, 2007
||United States: Food and Drug Administration
Keywords provided by Boston Scientific Corporation:
left ventricular lead
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014