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

Scandinavian Atrial Lead Trial

Status

Suspended

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180570

Acronym

SALT

Enrollment

385

Registered

2005-09-16

Start date

1997-01-31

Completion date

2006-01-31

Last updated

2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia

Brief 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

Interventions

DEVICEFineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* Patients who previously went through heart surgery should be excluded from the study.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to compare repositioning rate due to threshold > 3.0 V @ 0.5 ms or P-wave < 0.8 mV between FineLine II Sterox 4480 and 4470, and between 4456 and 4470.	—

Secondary

Measure	Time frame
1. Other complications (Safety). To compare other lead related complication rates such as perforation, lead fracture and failure to implant. 2. Electrical properties	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026