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

Bradycardia Clinical Trial

— SALT  

Official title:

Scandinavian Atrial Lead Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00180570
• Other study ID #: SALT-2
• Status: Suspended
• Phase: Phase 4
• First received: September 15, 2005
• Last updated: March 10, 2015
• Start date: January 1997
• Est. completion date: January 2006

Study information

• Verified date: September 2005
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 385
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bradycardia

Intervention

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

Locations

Country	Name	City	State
Sweden	Sahlgrenska Sjukhuset i Göteborg Sweden,	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
Guidant Corporation

Country where clinical trial is conducted

Sweden, 

Outcome

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