EASYTRAK 3 - Article
Clinical Trial: EASYTRAK 3
This study has been completed.
|Congestive Heart Failure || Device: EASYTRAK 3 left ventricular pacing lead ||Phase II |
MedlinePlus related topics: Heart Failure
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
Secondary Outcomes: left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
Expected Total Enrollment: 115
Study start: May 2003; Study completion: December 2004
Last follow-up: March 2004; Data entry closure: August 2004
- 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.
- 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.
Last Updated: September 11, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00158938
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13