Clinical trial NCT02235545: Optisure Lead Post Approval Study
Official title: Optisure Lead Post Approval Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Tachycardia, Ventricular
Keywords: HV Lead
ICD
CRT-D System
Treatment of Heart Failure
Treamtent of life-threatening ventricular tachyarrhythmia
Optisure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 1735
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICD/CRT-D indicated patients

Brief summary: The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.


Eligibility criteria: Inclusion Criteria:

Eligible patients will meet all of the following:

1. Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.
3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

1. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study.
2. Have a life expectancy of less than 5 years due to any condition.

Primary outcomes:
measure: Freedom from RV Lead Related Complications
timeFrame: Date at which all patients have completed their five year follow-up.
Secondary outcomes:
measure: Optisure Lead-Related Complication Rates
timeFrame: Date at which all patients have completed their five year follow-up.
Other outcomes:
measure: Optisure Lead Related Adverse Events
timeFrame: Date at which all patients have completed their five year follow-up.
measure: The annual hazard rate of lead electrical dysfunction
timeFrame: Date at which all patients have completed their five year follow-up.
measure: The annual hazard rate of externalized conductors
timeFrame: Date at which all patients have completed their five year follow-up.
measure: The annual hazard rate of other visual lead anomalies by each subcategory
timeFrame: Date at which all patients have completed their five year follow-up.
measure: Prevalence of "other insulation anomalies" in "returned leads
timeFrame: Date at which all patients have completed their five year follow-up.
measure: Time from externalized conductors to electrical dysfunction
timeFrame: Date at which all patients have completed their five year follow-up.
measure: Time from other visual lead anomalies by each subcategory to electrical dysfunction
timeFrame: Date at which all patients have completed their five year follow-up.
measure: Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other)
timeFrame: Date at which all patients have completed their five year follow-up.
measure: Time from externalized conductors to clinical intervention
timeFrame: Date at which all patients have completed their five year follow-up.
measure: Time from other visual lead anomalies by each subcategory to clinical intervention
timeFrame: Date at which all patients have completed their five year follow-up.
measure: Comparison of patients with lead compromise as evidenced by imaging (includes externalized conductors and other visual lead anomalies) to those without lead compromise
timeFrame: Date at which all patients have completed their five year follow-up.
measure: Comparison of patients with electrical dysfunction to those without electrical dysfunction.
timeFrame: Date at which all patients have completed their five year follow-up.
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Jonesboro
country: United States
facility: St. Bernards (formerly Cardiology Associates of Northeast Arkansas)
state: Arkansas
city: Burbank
country: United States
facility: Raymond Schaerf, MD
state: California
city: Palm Springs
country: United States
facility: Desert Heart Rhythm Consultants
state: California
city: Reseda
country: United States
facility: Cardiac Rhythm Specialists, Inc.
state: California
city: San Diego
country: United States
facility: San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)
state: California
city: Lake Mary
country: United States
facility: Jorge Diaz, M.D. , P.A.
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Rockford
country: United States
facility: Rockford Cardiology Associates
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Edgewood
country: United States
facility: St. Elizabeth Medical Center - South Unit
state: Kentucky
city: Salisbury
country: United States
facility: Peninsula Cardiology Associates
state: Maryland
city: Leominster
country: United States
facility: Mass Heart & Rhythm
state: Massachusetts
city: Flint
country: United States
facility: Premier Medical Clinics
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Traverse City
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Las Vegas
country: United States
facility: HealthCare Partners Cardiology
state: Nevada
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Brooklyn
country: United States
facility: Coney Island Hospital
state: New York
city: Liverpool
country: United States
facility: Cardiovascular Group of Syracuse
state: New York
city: High Point
country: United States
facility: High Point Regional Health (formerly Carolina Cardiology Cornerstone)
state: North Carolina
city: New Bern
country: United States
facility: CarolinaEast Heart Center
state: North Carolina
city: Cleveland
country: United States
facility: VA Medical Center Cleveland
state: Ohio
city: Willoughby
country: United States
facility: Great Lakes Medical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart and Vascular Institute
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Newtown
country: United States
facility: Arrhythmia Institute
state: Pennsylvania
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Bedford
country: United States
facility: HeartPlace
state: Texas
city: Dallas
country: United States
facility: VA Medical Center Dallas
state: Texas
city: El Paso
country: United States
facility: Cardiology Care Consultants
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Saint George
country: United States
facility: Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)
state: Utah
city: Fredericksburg
country: United States
facility: Mary Washington Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Halifax
country: Canada
facility: QE II Health Sciences
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Scarborough
country: Canada
facility: Rouge Valley Centenary
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen
city: Shinjuku-Ku
country: Japan
facility: Tokyo Women's Medical University
state: Kanto
city: Abeno-ku
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi-ken
city: Lodz
country: Poland
facility: Mc-Tronik
city: Lisboa
country: Portugal
facility: Santa Maria Hospital
state: Lisbon
Study officials:
affiliation: Abbott Medical Devices
name: Grant Kim
role: STUDY_DIRECTOR
References: