SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes
Sponsor
Guidant Corporation (Industry)
Overall Status
Suspended
CT.gov ID
NCT00180570
Collaborator
(none)
385
1
108
3.6
Study Details
Study Description
Brief Summary
Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Scandinavian Atrial Lead Trial
Study Start Date
:
Jan 1, 1997
Study Completion Date
:
Jan 1, 2006
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sahlgrenska Sjukhuset i Göteborg Sweden, | Goteborg | Sweden |
Sponsors and Collaborators
- Guidant Corporation
Investigators
- Principal Investigator: charles kennergren, Sahlgrenska Sjukhuset i Göteborg Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00180570
Other Study ID Numbers:
- SALT-2
First Posted:
Sep 16, 2005
Last Update Posted:
Mar 11, 2015
Last Verified:
Sep 1, 2005
Additional relevant MeSH terms: