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Clinical Investigation of the SelectSecure Pacing Lead

NCT ID: NCT00266682

Last Updated: 2006-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2005-08-31

Brief Summary

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People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area. This device helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The purpose of this study is to demonstrate that the SelectSecure (Model 3830) lead is safe and effective for both sensing the heart's natural rhythm and pacing the heart when it does not beat on its own. This lead will be studied in both the right atrium and right ventricle. A previously market approved Medtronic lead model will serve as a comparison to prove the safety and effectiveness of the SelectSecure Model.

Detailed Description

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Conditions

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Bradycardia

Keywords

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Bradycardia

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pacing Lead

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Locations

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Anchorage, Alaska, United States

Site Status

Peoria, Arizona, United States

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Long Beach, California, United States

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Santa Rosa, California, United States

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Fort Lauderdale, Florida, United States

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Evanston, Illinois, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Robbinsdale, Minnesota, United States

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Saint Paul, Minnesota, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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Livingston, New Jersey, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Lancaster, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Temple, Texas, United States

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Richmond, Virginia, United States

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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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Countries

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United States Australia Canada

Other Identifiers

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600

Identifier Type: -

Identifier Source: org_study_id