Optisure Lead Post Approval Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Abbott Medical Devices
Study ID
NCT02235545
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • St. Jude Medical Optisure Lead — DEVICE
    Patients implanted with St. Jude Medical Optisure Lead

Study Details

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

Key Dates

Start date
Aug 31, 2014
Status verified
Jul 2025
Primary completion
Dec 16, 2019
Completion
Jun 30, 2020

Study Design

Enrollment
1,735 participants (actual)

Arms

  • Arm: St. Jude Medical Optisure Lead
    Patients implanted with St. Jude Medical Optisure Lead

Primary Outcome Measure

Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads. [ Time Frame: 5 years ]

Locations (46)

FacilityCityStateZIPSite coordinators
Baptist Medical Center PrincetonBirminghamAlabama35211-
Phoenix Cardiovascular Research GroupPhoenixArizona85018-
St. Bernards (formerly Cardiology Associates of Northeast Arkansas)JonesboroArkansas72401-
Raymond Schaerf, MDBurbankCalifornia91505-
Desert Heart Rhythm ConsultantsPalm SpringsCalifornia92262-
Cardiac Rhythm Specialists, Inc.ResedaCalifornia91335-
San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)San DiegoCalifornia92103-
Jorge Diaz, M.D. , P.A.Lake MaryFlorida32746-
Northside HospitalAtlantaGeorgia30342-
Rockford Cardiology AssociatesRockfordIllinois61107-
Parkview Research CenterFort WayneIndiana46845-
Iowa Heart CenterWest Des MoinesIowa50266-
St. Elizabeth Medical Center - South UnitEdgewoodKentucky41017-
Peninsula Cardiology AssociatesSalisburyMaryland21804-
Mass Heart & RhythmLeominsterMassachusetts01453-
Premier Medical ClinicsFlintMichigan48532-
Genesys Regional Medical CenterGrand BlancMichigan48439-
Northern Michigan HospitalTraverse CityMichigan49684-
Minneapolis Heart InstituteMinneapolisMinnesota55407-
Jackson Heart ClinicJacksonMississippi39216-
Cardiology Associates of North MississippiTupeloMississippi38801-
HealthCare Partners CardiologyLas VegasNevada89109-
Cardiovascular Associates of the Delaware ValleyHaddon HeightsNew Jersey08035-
Lourdes Cardiology ServicesVoorhees TownshipNew Jersey08043-
Presbyterian Heart GroupAlbuquerqueNew Mexico87106-
Coney Island HospitalBrooklynNew York11235-
Maimonides Medical CenterBrooklynNew York11219-
Cardiovascular Group of SyracuseLiverpoolNew York13088-
High Point Regional Health (formerly Carolina Cardiology Cornerstone)High PointNorth Carolina27262-
CarolinaEast Heart CenterNew BernNorth Carolina28562-
VA Medical Center ClevelandClevelandOhio44106-
Great Lakes Medical Research, LLCWilloughbyOhio44094-
Integris Baptist Medical CenterOklahoma CityOklahoma73112-
Providence Heart and Vascular InstitutePortlandOregon97225-
Lehigh Valley HospitalAllentownPennsylvania18105-
Lancaster General HospitalLancasterPennsylvania17602-
Arrhythmia InstituteNewtownPennsylvania18940-
The Stern Cardiovascular FoundationGermantownTennessee38138-
HeartPlaceBedfordTexas76021-
VA Medical Center DallasDallasTexas75216-
Cardiology Care ConsultantsEl PasoTexas79936-
Scott & White Memorial HospitalTempleTexas76508-
Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)St. GeorgeUtah84790-
Mary Washington HospitalFredericksburgVirginia22401-
Virginia Cardiovascular SpecialistsRichmondVirginia23229-
Aurora Medical GroupMilwaukeeWisconsin53215-

Find similar trials in Birmingham, AL

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Baptist Medical Center Princeton· Birmingham, ALPhoenix Cardiovascular Research Group· Phoenix, AZSt. Bernards (formerly Cardiology Associates of Northeast Arkansas)· Jonesboro, ARRaymond Schaerf, MD· Burbank, CADesert Heart Rhythm Consultants· Palm Springs, CACardiac Rhythm Specialists, Inc.· Reseda, CA

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