Clinical Investigation of the SelectSecure Pacing Lead

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00266682
First received: December 16, 2005
Last updated: October 11, 2006
Last verified: October 2006
  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
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation of the SelectSecure Pacing Lead

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266682

  Show 31 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00266682     History of Changes
Other Study ID Numbers: 600
Study First Received: December 16, 2005
Last Updated: October 11, 2006
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Bradycardia

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

ClinicalTrials.gov processed this record on August 27, 2014