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

March 10, 2015 updated by: Guidant Corporation

Scandinavian Atrial Lead Trial

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

385

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Goteborg, Sweden
        • Sahlgrenska Sjukhuset i Göteborg Sweden,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guidant Corporation

Investigators

  • Principal Investigator: charles kennergren, Sahlgrenska Sjukhuset i Göteborg Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (ESTIMATE)

September 16, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALT-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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