Back to resultsSALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes (SALT)
Primary Purpose
Bradycardia
Status
Suspended
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ
Sponsored by
About this trial
This is an interventional treatment trial for Bradycardia
Eligibility 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.
Sites / Locations
- Sahlgrenska Sjukhuset i Göteborg Sweden,
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00180570
Brief Title
SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes
Acronym
SALT
Official Title
Scandinavian Atrial Lead Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Suspended
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Guidant Corporation
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
385 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
1. Other complications (Safety). To compare other lead related complication rates such as perforation, lead fracture and failure to implant. 2. Electrical properties
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
charles kennergren
Organizational Affiliation
Sahlgrenska Sjukhuset i Göteborg Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska Sjukhuset i Göteborg Sweden,
City
Goteborg
Country
Sweden
12. IPD Sharing Statement
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SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes
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