SALT - Full Text View - ClinicalTrials.gov

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00180570

Purpose

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

Condition	Intervention	Phase
Bradycardia	Device: FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Scandinavian Atrial Lead Trial

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	385
Study Start Date:	January 1997
Estimated Study Completion Date:	January 2006

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180570

Locations

Sweden
Sahlgrenska Sjukhuset i Göteborg Sweden,
Goteborg, Sweden

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:

charles kennergren

Sahlgrenska Sjukhuset i Göteborg Sweden

More Information

Study ID Numbers:	SALT-2
Study First Received:	September 15, 2005
Last Updated:	September 15, 2005
ClinicalTrials.gov Identifier:	NCT00180570
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Heart Diseases
Bradycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009