Clinical trial NCT01361685: Model 4396 Left Ventricular (LV) Lead Chronic Performance Study
Official title: Attain Ability® Family Left Ventricular Lead Chronic Performance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2011-05-27
Enrollment: 366
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 4396 LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Brief summary: Lead survivability will be summarized.

Detailed description: The purpose of this study is to evaluate long-term performance of the 4396 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 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

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 4396 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: Model 4396 LV Lead-related complication rate
timeFrame: 5 years
Secondary outcomes:
measure: Types of lead-related adverse device effects
timeFrame: 5 years
measure: Percent of subjects with changes in electrode programming
timeFrame: 5 years
measure: Number of fractures with and without loss of function
timeFrame: 5 years
measure: Bipolar electrical performance at 1 year
timeFrame: 1 year
measure: Bipolar pacing impedance
timeFrame: 1 year
measure: Bipolar pacing capture threshold
timeFrame: 1 year
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Southwest EP Clinic
state: Arizona
city: Little Rock
country: United States
facility: Saint Vincent Heart Clinic Arkansas
state: Arkansas
city: Rancho Mirage
country: United States
facility: Eisenhower Desert Cardiology Center
state: California
city: Torrance
country: United States
facility: COR Healthcare
state: California
city: Van Nuys
country: United States
facility: Cardiovascular Consultants Medical Group
state: California
city: Lakewood
country: United States
facility: Colorado Heart and Vascular, PC
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: MedStar Southern Maryland Hospital Center
state: District of Columbia
city: Bradenton
country: United States
facility: Bradenton Cardiology
state: Florida
city: Jacksonville
country: United States
facility: Baptist Heart Specialists
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health - Methodist Research Institute
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Louisville
country: United States
facility: Louisville Cardiology Group
state: Kentucky
city: Alexandria
country: United States
facility: Cenla Heart Specialists
state: Louisiana
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Office of Research
state: Louisiana
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Coon Rapids
country: United States
facility: Metropolitan Cardiology Consultants PA
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Heart and Vascular Institute
state: Minnesota
city: Saint Louis Park
country: United States
facility: HealthCare Partners Medical Group
state: Minnesota
city: Kansas City
country: United States
facility: Saint Lukes Health System
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Washington
country: United States
facility: Patients First Health Care LLC
state: Missouri
city: West Orange
country: United States
facility: New Jersey Cardiology Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Columbia University Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: Utica
country: United States
facility: Central New York Cardiology
state: New York
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Health Network
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Bethlehem
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Erie
country: United States
facility: Medicor Associates
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: San Antonio
country: United States
facility: STAR Clinical Trials
state: Texas
city: The Woodlands
country: United States
facility: EP Heart LLC
state: Texas
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: Kingston
country: Canada
facility: Queen's University & Kingston General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM) Hopital Hotel-Dieu
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
state: Baden-württemberg
Study officials:
References: