Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
Phase 2
Completed
- Conditions
- Congestive Heart Failure
- Registration Number
- NCT00158938
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
- Detailed Description
This clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the EASYTRAK 3 lead in humans. Patients implanted with the EASYTRAK 3 lead were followed through pre-discharge, 1-month, 3-month and 6-month follow-ups
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pacing thresholds at 6 months Pacing impedances at 6 months R-wave amplitudes at 6 months 6-month complication free rate
- Secondary Outcome Measures
Name Time Method left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety