NCT00266682

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
365

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2002

Typical duration for not_applicable

Geographic Reach
3 countries

31 active sites

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

August 1, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2005

Completed
Last Updated

October 13, 2006

Status Verified

October 1, 2006

First QC Date

December 16, 2005

Last Update Submit

October 11, 2006

Conditions

Bradycardia

Keywords

Bradycardia

Outcome Measures

Primary Outcomes (1)

  • 3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives

Secondary Outcomes (1)

  • Lead and catheter handling characteristics, and lead impedance

Interventions

Pacing LeadDEVICE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are in need of a pacemaker that paces in both the right atrium and ventricle.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Unknown Facility

Anchorage, Alaska, United States

Location

Unknown Facility

Peoria, Arizona, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Santa Rosa, California, United States

Location

Unknown Facility

Fort Lauderdale, Florida, United States

Location

Unknown Facility

Evanston, Illinois, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Des Moines, Iowa, United States

Location

Unknown Facility

Iowa City, Iowa, United States

Location

Unknown Facility

Kansas City, Kansas, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Robbinsdale, Minnesota, United States

Location

Unknown Facility

Saint Paul, Minnesota, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

Springfield, Missouri, United States

Location

Unknown Facility

Livingston, New Jersey, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Lancaster, Pennsylvania, United States

Location

Unknown Facility

Sayre, Pennsylvania, United States

Location

Unknown Facility

Germantown, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Temple, Texas, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Melbourne, Australia

Location

Unknown Facility

Kingston, Canada

Location

Unknown Facility

London, Canada

Location

Unknown Facility

Ottawa, Canada

Location

Unknown Facility

Sainte-Foy, Canada

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 16, 2005

First Posted

December 19, 2005

Study Start

August 1, 2002

Study Completion

August 1, 2005

Last Updated

October 13, 2006

Record last verified: 2006-10

Locations

US(26)CA(4)AU(1)