Clinical trial NCT00893386: Attain StarFix® 4195 Lead Extraction Study
Official title: Attain StarFix® Model 4195 LV Lead Extraction Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Indications for Lead Removal
Keywords: Extraction
Removal
Lead
Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-05-06
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be chosen by investigators participating in the study at up to 25 experienced extraction centers throughout the United States and Canada. Patients of both genders that are indicated for a Model 4195 or a non-Model 4195 Medtronic lead extraction who meet all inclusion criteria may be in the study.

Brief summary: The purpose of this study is to characterize the removability of the Attain StarFix® Model 4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead removal success in patients that are indicated for left ventricular lead removal. This study is required by the Food and Drug Administration (FDA) as a condition of approval for the Attain StarFix® Model 4195 LV Lead.


Eligibility criteria: Inclusion Criteria:

* Subjects with a Class I/II indication and/or physician discretion for left ventricular lead removal
* Medtronic Model 4195 LV lead implanted for at least 181 days at time of extraction, or other Medtronic LV Lead (non-Model 4195) implanted for at least 181 days at time of extraction, or Medtronic Model 4195 LV lead implanted for 90-180 days
* Intention to remove the LV lead prior to the extraction procedure
* Subject is 18 years of age or older
* Subject (or subject's legally authorized representative) has signed and dated the Patient Consent Form and is willing and able to comply with the protocol

Exclusion Criteria:

* None

Primary outcomes:
measure: Removal success of LV leads implanted for more than 180 days
timeFrame: More than 180 days post-implant
Secondary outcomes:
measure: Success of lead removal by how long the lead has been implanted
timeFrame: More than 180 days post-implant
measure: Adverse Events that are related to the LV lead, the extraction procedure, or the extraction tool.
timeFrame: 0 to 45 days post-lead extraction
measure: Removal success of Medtronic Model 4195 LV Leads implanted for 90-180 days
timeFrame: 90 -180 days post-implant
measure: Summary of tools & techniques used to remove LV leads.
timeFrame: More than 180 days post-implant
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Burbank
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: St. Paul
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Sainte-Foy
country: Canada
state: Quebec
Study officials:
affiliation: Medtronic
name: 4195 Extraction Study Team
role: STUDY_CHAIR
References: