EASYTRAK 3 Downsize Lead

Boston Scientific

Status and phase

Completed

Phase 3

Phase 2

Conditions

Heart Failure

Treatments

Device: EASYTRAK 3 Downsize Lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT00384722

Clinicals0011

Details and patient eligibility

About

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.

Full description

This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must be indicated for a 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 0.5 mg 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.