Clinical trial NCT00384722: EASYTRAK 3 Downsize Lead
Official title: EASYTRAK® 3 Downsize Lead Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Keywords: Left ventricular lead
Pacing
Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lead-related complication-free rate at one-month
timeFrame: 1 month
measure: Chronic mean pacing thresholds at one-month.
timeFrame: 1 month
Secondary outcomes:
measure: Chronic mean R-wave amplitudes at one-month
timeFrame: 1 month
measure: Chronic mean pacing impedances at one-month.
timeFrame: 1 month
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Multiple Locations
state: Minnesota
Study officials:
affiliation: Riverside Methodist Hospital
name: John Hummel, MD
role: PRINCIPAL_INVESTIGATOR
References: