NCT00180570

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

Scandinavian Atrial Lead Trial

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 385 (planned)
• Sponsor: Guidant Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Bradycardia

Interventions

Type	Name	Description
DEVICE	FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ

Timeline

• Start date: 1997-01-01
• Completion: 2006-01-01
• First posted: 2005-09-16
• Last updated: 2015-03-11

Locations

1 site across 1 country: Sweden