Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead

NCT00158938 | Completed Phase 2

• 1 other identifier: Clinicals0007
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead

Conditions

Congestive Heart Failure

Keywords

Artificial Cardiac Pacemaker; Implanted Electrodes

Outcome Measures

Primary Outcomes (4)

• Pacing thresholds at 6 months

• Pacing impedances at 6 months

• R-wave amplitudes at 6 months

• 6-month complication free rate

Secondary Outcomes (1)

• left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety

Interventions

EASYTRAK 3 left ventricular pacing lead DEVICE

Eligibility Criteria

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

You may qualify if:

• Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF \<= 35%) and QRS duration \>= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy.
• 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 investigational center and at the intervals defined by this protocol.

You may not qualify if:

• A known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate.
• Previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement.
• Pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads).
• Requiring dialysis.
• A myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment.
• Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
• A documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months.
• Enrolled in any concurrent study, without prior Guidant written approval, that may confound the results of this study.
• Have a mechanical tricuspid heart valve.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

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: May 1, 2003
• Study Completion: November 1, 2004
• Last Updated: June 25, 2007

Record last verified: 2007-06