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| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 9, 2005 |
| Last Updated Date | December 19, 2007 |
| Start Date ICMJE | November 2004 |
| Primary Completion Date | May 2005 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00180284 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | SITELINE 2 Polyurethane |
| Official Title ICMJE | SITELINE 2 Polyurethane Clinical Investigation |
| Brief Summary | The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead. |
| Detailed Description | This was a prospective, single-arm, multi-center U.S. clinical investigation, designed to demonstrate the safety and effectiveness of the SITELINE 2 Polyurethane extendable, retractable pacing lead in humans |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Condition ICMJE | Bradycardia |
| Intervention ICMJE | Device: SITELINE 2 Polyurethane (pacing lead) |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Enrollment ICMJE | 200 |
| Estimated Completion Date | February 2008 |
| Primary Completion Date | May 2005 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00180284 |
| Responsible Party | Steve McQuillan, Director of Clinical Affairs, Boston Scientific |
| Study ID Numbers ICMJE | Clinicals0009 |
| Study Sponsor ICMJE | Boston Scientific Corporation |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Boston Scientific Corporation |
| Verification Date | December 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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