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Clinical Investigation of the SelectSecure Pacing Lead

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00266682
First Posted: December 19, 2005
Last Update Posted: October 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure
  Purpose
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.

Condition Intervention
Bradycardia Device: Pacing Lead

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the SelectSecure Pacing Lead

Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

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

Secondary Outcome Measures:
  • Lead and catheter handling characteristics, and lead impedance

Estimated Enrollment: 365
Study Start Date: August 2002
Estimated Study Completion Date: August 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266682


  Show 31 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
  More Information

ClinicalTrials.gov Identifier: NCT00266682     History of Changes
Other Study ID Numbers: 600
First Submitted: December 16, 2005
First Posted: December 19, 2005
Last Update Posted: October 13, 2006
Last Verified: October 2006

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Bradycardia

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes