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Completed

NCT Number: NCT00180284

SITELINE 2 Polyurethane

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

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Multiple Locations in the United States

Saint Paul, Minnesota, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SITELINE 2 Polyurethane (pacing lead)

Device

SITELINE 2 Polyurethane (pacing lead)

Primary outcomes

  1. Pacing voltage threshold at 3 Months

    Time frame: 3 months

  2. Pacing impedance at 3 Months

    Time frame: 3 months

  3. Sensed amplitude at 3 Months

    Time frame: 3 months

  4. Lead complication-free rate up to 3 Months

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

SITELINE 2 Polyurethane Clinical Investigation

Important dates

Study start
2004
Primary completion
2005
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Sep 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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