NCT00180284

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

6 months

First QC Date

September 9, 2005

Last Update Submit

September 28, 2011

Conditions

Bradycardia

Keywords

Pacemaker leadsElectrodes, implantableCardiac pacing, aritificial

Outcome Measures

Primary Outcomes (4)

  • Pacing voltage threshold at 3 Months

    3 months

  • Pacing impedance at 3 Months

    3 months

  • Sensed amplitude at 3 Months

    3 months

  • Lead complication-free rate up to 3 Months

    3 months

Interventions

SITELINE 2 Polyurethane (pacing lead)DEVICE

SITELINE 2 Polyurethane (pacing lead)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Locations in the United States

Saint Paul, Minnesota, United States

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

November 1, 2004

Primary Completion

May 1, 2005

Study Completion

February 1, 2008

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

US(1)