SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes

Guidant

Status and phase

Suspended

Phase 4

Conditions

Bradycardia

Treatments

Device: FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ

Study type

Interventional

Funder types

Industry

Identifiers

NCT00180570

SALT-2

Details and patient eligibility

About

Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism

Full description

This investigation will study and compare 3 types of electrically identical, commercially available FineLine II Sterox leads with different fixation mechanisms. This trial has been designed to primarily study the difference in repositioning rate between active and passive fixation (straight and J-shaped) leads, if any. It will also monitor and document the behavior of the study leads, with special reference to electrical parameters and handling. Normal measurements are taken at pre-dicharge, 1-month 3-month and 12-month follow-up

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients selected for participation in this investigation should be candidates for permanent pacemaker implantation chosen from the investigator's general patient population without regard for race or sex. Furthermore, these patients should, in the physician's general opinion, benefit from permanent pacemaker implantation with one of the study leads. Patients should be geographically stable and available for routine follow-up visits throughout the duration of the study. Patients must also be able and willing to provide informed consent.

Exclusion criteria