Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
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ClinicalTrials.gov Identifier: NCT00158938 |
Recruitment Status
:
Completed
First Posted
: September 12, 2005
Last Update Posted
: June 25, 2007
|
Sponsor:
Boston Scientific Corporation
Information provided by:
Boston Scientific Corporation
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Brief Summary:
The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congestive Heart Failure | Device: EASYTRAK 3 left ventricular pacing lead | Phase 2 Phase 3 |
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
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 115 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead |
Study Start Date : | May 2003 |
Actual Study Completion Date : | November 2004 |
Primary Outcome Measures
:
- Pacing thresholds at 6 months
- Pacing impedances at 6 months
- R-wave amplitudes at 6 months
- 6-month complication free rate
Secondary Outcome Measures
:
- left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
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.
No Contacts or Locations Provided
ClinicalTrials.gov Identifier: | NCT00158938 History of Changes |
Other Study ID Numbers: |
Clinicals0007 |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | June 25, 2007 |
Last Verified: | June 2007 |
Keywords provided by Boston Scientific Corporation:
Artificial Cardiac Pacemaker Implanted Electrodes |
Additional relevant MeSH terms:
Heart Failure Heart Diseases Cardiovascular Diseases |