Congestive Heart Failure
Conditions
Keywords
Artificial Cardiac Pacemaker, Implanted Electrodes
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
Interventions
DEVICEEASYTRAK 3 left ventricular pacing lead
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pacing thresholds at 6 months | — |
| Pacing impedances at 6 months | — |
| R-wave amplitudes at 6 months | — |
| 6-month complication free rate | — |
Secondary
| Measure | Time frame |
|---|---|
| left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety | — |
Outcome results
None listed