- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00266682
Clinical Investigation of the SelectSecure Pacing Lead
Study Overview
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Melbourne, Australia
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Kingston, Canada
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London, Canada
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Ottawa, Canada
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Sainte-Foy, Canada
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Alaska
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Anchorage, Alaska, United States
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Arizona
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Peoria, Arizona, United States
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California
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Long Beach, California, United States
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Santa Rosa, California, United States
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Florida
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Fort Lauderdale, Florida, United States
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Illinois
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Evanston, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Iowa
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Des Moines, Iowa, United States
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Iowa City, Iowa, United States
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Kansas
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Kansas City, Kansas, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Detroit, Michigan, United States
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Minnesota
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Robbinsdale, Minnesota, United States
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St. Paul, Minnesota, United States
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Missouri
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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New Jersey
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Livingston, New Jersey, United States
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North Carolina
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Winston-Salem, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Pennsylvania
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Lancaster, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Tennessee
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Austin, Texas, United States
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Temple, Texas, United States
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Virginia
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Richmond, Virginia, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects who are in need of a pacemaker that paces in both the right atrium and ventricle.
Exclusion Criteria:
Subjects who are in need of an implantable cardioverter defibrillator (ICD).
Subjects who have a mechanical or diseased tricuspid valve (a structure in the heart, located between the right atrium and right ventricle, which allows blood to flow from the atrium to the ventricle).
Steroid contraindication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives
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Secondary Outcome Measures
Outcome Measure |
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Lead and catheter handling characteristics, and lead impedance
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 600
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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