SITELINE 2 Polyurethane - Full Text View

Sponsor:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00180284

Purpose

The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.

Condition	Intervention	Phase
Bradycardia	Device: SITELINE 2 Polyurethane (pacing lead)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	SITELINE 2 Polyurethane Clinical Investigation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

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 ]

Enrollment:	200
Study Start Date:	November 2004
Estimated Study Completion Date:	February 2008
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180284

Locations

United States, Minnesota
Multiple Locations in the United States
St. Paul, Minnesota, United States

Sponsors and Collaborators

Boston Scientific Corporation

More Information

No publications provided

Responsible Party:	Boston Scientific ( Steve McQuillan, Director of Clinical Affairs )
Study ID Numbers:	Clinicals0009
Study First Received:	September 9, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00180284 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

Pacemaker leads
Electrodes, implantable
Cardiac pacing, aritificial

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Bradycardia
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 30, 2009