Clinical Investigation of the SelectSecure Pacing Lead
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 365
- Locations
- 30
- Primary Endpoint
- 3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives
Secondary Outcomes
- Lead and catheter handling characteristics, and lead impedance