EASYTRAK 4 Steerable LV Lead

NCT00158964 | Completed Phase 2

• 1 other identifier: Clinicals0006
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.

Conditions

Heart Failure

Keywords

left ventricular lead; pacing; heart failure

Outcome Measures

Primary Outcomes (2)

• Lead-related complication free-rate at 3-months.

• Chronic mean pacing thresholds at 3-months.

Secondary Outcomes (2)

• Chronic Mean pacing impedances at 3-months

• Chronic Mean R-wave amplitudes at 3-months

Interventions

EASYTRAK 4 STEERABLE LV lead DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Multiple locations

Saint Paul, Minnesota, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Stephen Mester, MD

  Tampa General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 2005
• Study Completion: April 1, 2007
• Last Updated: June 25, 2007

Record last verified: 2007-06

Locations

US (1)