Bradycardia
Conditions
Keywords
Pacemaker leads, Electrodes, implantable, Cardiac pacing, aritificial
Brief summary
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
Detailed description
This was a prospective, single-arm, multi-center U.S. clinical investigation, designed to demonstrate the safety and effectiveness of the SITELINE 2 Polyurethane extendable, retractable pacing lead in humans
Interventions
DEVICESITELINE 2 Polyurethane (pacing lead)
SITELINE 2 Polyurethane (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
* Patients indicated for dual chamber pulse generator implant, where the pulse generator is capable of meeting the requirements of this investigational protocol * Patients selected must have the study lead as the initial implant of a permanent pacing lead in both the right atrium and the right ventricle * Age 18 or above, or of legal age to give informed consent specific to state and national law * Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation * Available for follow-up at an approved clinical investigational center, at the protocol-defined intervals * A life expectancy of more than 180 days
Exclusion criteria
* Have or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation * Have surgically uncorrected primary valvular heart disease * Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) * Requiring ICD therapy * Have a hypersensitivity to a nominal single dose of 1.0 mg (0.5 mg per electrode) of dexamethasone acetate drug * Enrolled in any concurrent study, including drug investigation, without Guidant written approval, that may confound the results of this study * Women who are pregnant or plan to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pacing voltage threshold at 3 Months | 3 months |
| Pacing impedance at 3 Months | 3 months |
| Sensed amplitude at 3 Months | 3 months |
| Lead complication-free rate up to 3 Months | 3 months |
Countries
United States
Outcome results
None listed