Heart Failure
Conditions
Keywords
left ventricular lead, pacing, heart failure
Brief summary
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
Detailed description
This is a prospective, multi-center clinical study is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
Interventions
DEVICEEASYTRAK 4 STEERABLE LV lead
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lead-related complication free-rate at 3-months. | — |
| Chronic mean pacing thresholds at 3-months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Chronic Mean pacing impedances at 3-months | — |
| Chronic Mean R-wave amplitudes at 3-months | — |
Countries
United States
Outcome results
None listed