Clinical trial NCT00266682: Clinical Investigation of the SelectSecure Pacing Lead
Official title: Clinical Investigation of the SelectSecure Pacing Lead
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Keywords: Bradycardia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2005-12-19
Enrollment: 365
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives
Secondary outcomes:
measure: Lead and catheter handling characteristics, and lead impedance
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Peoria
country: United States
state: Arizona
city: Long Beach
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Fort Lauderdale
country: United States
state: Florida
city: Evanston
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Robbinsdale
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Livingston
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Lancaster
country: United States
state: Pennsylvania
city: Sayre
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Melbourne
country: Australia
city: Kingston
country: Canada
city: London
country: Canada
city: Ottawa
country: Canada
city: Sainte-Foy
country: Canada
Study officials:
References: