Clinical trial NCT00869921: Model 4195 Left Ventricular (LV) Lead Chronic Performance Study
Official title: Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2009-03-26
Enrollment: 1322
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with a 4195 LV Lead within the past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.

Brief summary: Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.

Detailed description: Model 4195 LV lead complication-free survivability will be summarized.

Eligibility criteria: Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive an Attain StarFix Model 4195 LV lead
* Patient within 30 day post implant enrollment window

Exclusion Criteria

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Primary outcomes:
measure: Lead-related complication rate.
timeFrame: Implant to 5 years post-implant.
Secondary outcomes:
measure: Types of Model 4195 lead-related events
timeFrame: 5 years post implant
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Chula Vista
country: United States
state: California
city: Redding
country: United States
state: California
city: Salinas
country: United States
state: California
city: Stanford
country: United States
state: California
city: Torrance
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Albany
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Edgewood
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Covington
country: United States
state: Louisiana
city: Salisbury
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Grand Blanc
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Robbinsdale
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Saint Louis Park
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: West Orange
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Lancaster
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Falls Church
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Calgary
country: Canada
state: Alberta
city: Kingston
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Quebec City
country: Canada
state: Quebec
city: Middlesbrough
country: United Kingdom
Study officials:
affiliation: Medtronic
name: 4195 LV Lead Chronic Performance Study Team
role: STUDY_CHAIR
References: