SITELINE 2 Polyurethane - Tabular View

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 (submitted: December 19, 2007)	Pacing voltage threshold at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] Pacing impedance at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] Sensed amplitude at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] Lead complication-free rate up to 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: September 9, 2005)	Pacing voltage threshold at 3 Months Pacing impedance at 3 Months Sensed amplitude at 3 Months Lead complication-free rate up to 3 Months
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 *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

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: Patients indicated for dual chamber pulse generator implant, where the pulse generator is capable of meeting the requirements of this investigational protocol Patients selected must have the study lead as the initial implant of a permanent pacing lead in both the right atrium and the right ventricle Age 18 or above, or of legal age to give informed consent specific to state and national law Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation Available for follow-up at an approved clinical investigational center, at the protocol-defined intervals A life expectancy of more than 180 days Exclusion Criteria: Have or who are likely to receive a mechanical tricuspid valve during the course of the clinical investigation Have surgically uncorrected primary valvular heart disease Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) Requiring ICD therapy Have a hypersensitivity to a nominal single dose of 1.0 mg (0.5 mg per electrode) of dexamethasone acetate drug Enrolled in any concurrent study, including drug investigation, without Guidant written approval, that may confound the results of this study Women who are pregnant or plan to become pregnant
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
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP