EASYTRAK 3 Downsize Lead

Phase 2

Completed

• Conditions: Heart Failure

• Registration Number: NCT00384722
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2006-07
• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-03
• Study First Posted: 2006-10-06
• Study Completion: 2008-05
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-23
• Last Update Posted: 2009-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Lead-related complication-free rate at one-month	1 month
Chronic mean pacing thresholds at one-month.	1 month

Secondary Outcome Measures

Name	Time	Method
Chronic mean R-wave amplitudes at one-month	1 month
Chronic mean pacing impedances at one-month.	1 month

Trial Locations

Locations (1)

Multiple Locations; 🇺🇸 St. Paul, Minnesota, United States