Clinical Investigation of the SelectSecure Pacing Lead

Bradycardia Clinical Trial

Official title:

Clinical Investigation of the SelectSecure Pacing Lead

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266682
• Other study ID #: 600
• Status: Completed
• Phase: N/A
• First received: December 16, 2005
• Last updated: October 11, 2006
• Start date: August 2002
• Est. completion date: August 2005

Study information

• Verified date: October 2006
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• Pacing Lead

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives
Secondary	Lead and catheter handling characteristics, and lead impedance