Clinical trial NCT00930904: Model 4196 Left Ventricular (LV) Lead Chronic Performance Study
Official title: Attain Ability® Model 4196 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: 2009-07-02
Enrollment: 1847
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 4196 LV Lead within the past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.

Brief summary: The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring 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 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).

Detailed description: Model 4196 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 Ability Model 4196 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: 5 years
Secondary outcomes:
measure: Types of lead-related events
timeFrame: 5 years
measure: Percent of subjects with changes in electrode programming
timeFrame: 5 Years
measure: Percent of fractures with loss of function
timeFrame: 5 years
measure: Mean bipolar pacing threshold
timeFrame: 1 year
measure: Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Gilbert
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Downey
country: United States
state: California
city: East Palo Alto
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Salinas
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: Torrance
country: United States
state: California
city: Van Nuys
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
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: Wellington
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Oak Lawn
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Alexandria
country: United States
state: Louisiana
city: Baton Rouge
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Grand Blanc
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Robbinsdale
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Browns Mills
country: United States
state: New Jersey
city: Ocean City
country: United States
state: New Jersey
city: Parlin
country: United States
state: New Jersey
city: West Orange
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Huntington
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Akron
country: United States
state: Ohio
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: Erie
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Sayre
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Florence
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
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: San Antonio
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Fairfax
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: Linz
country: Austria
city: Hasselt
country: Belgium
city: Ottawa
country: Canada
state: Ontario
city: Ste-Foy
country: Canada
state: Quebec
city: Kingston
country: Canada
city: Toronto
country: Canada
city: Marseille
country: France
city: Reggio Emilia
country: Italy
city: Udine
country: Italy
city: Eindhoven
country: Netherlands
city: Rotterdam
country: Netherlands
city: Valencia
country: Spain
Study officials:
affiliation: Medtronic
name: 4196 LV Lead Chronic Performance Study Team
role: STUDY_CHAIR
References: