SITELINE 2 Polyurethane

Bradycardia Clinical Trial

Official title:

SITELINE 2 Polyurethane Clinical Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180284
• Other study ID #: Clinicals0009
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: September 28, 2011
• Start date: November 2004
• Est. completion date: February 2008

Study information

• Verified date: September 2011
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2008
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• SITELINE 2 Polyurethane (pacing lead)
SITELINE 2 Polyurethane (pacing lead)

Locations

Country	Name	City	State
United States	Multiple Locations in the United States	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pacing voltage threshold at 3 Months		3 months	Yes
Primary	Pacing impedance at 3 Months		3 months	Yes
Primary	Sensed amplitude at 3 Months		3 months	Yes
Primary	Lead complication-free rate up to 3 Months		3 months	Yes