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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	September 8, 2005
Last Updated Date	June 22, 2007
Start Date ^†	May 2003
Current Primary Outcome Measures ^† (submitted: June 22, 2007)	Pacing thresholds at 6 months Pacing impedances at 6 months R-wave amplitudes at 6 months 6-month complication free rate
Original Primary Outcome Measures ^† (submitted: September 11, 2005)	Pacing thresholds at 6 months Pacing impedances at 6 months R-wave amplitudes at 6 months 6-month complication free rate
Change History	Complete list of historical versions of study NCT00158938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: September 11, 2005)	left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
Official Title ^†	Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
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
Study Phase	Phase II, Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^†	Congestive Heart Failure
Intervention ^†	Device: EASYTRAK 3 left ventricular pacing lead
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	115
Completion Date	November 2004
Primary Completion Date
Eligibility 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00158938
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Boston Scientific Corporation
Collaborators ^††
Investigators ^†
Information Provided By	Boston Scientific Corporation
Verification Date	June 2007
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.