Lead Evaluation for Defibrillation and Reliability Post Approval Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Medtronic
Study ID
NCT07005232
Status
Enrolling By Invitation

Conditions

  • Tachyarrhythmia

Eligibility Criteria

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

Interventions

  • defibrillation lead — DEVICE
    This is a device registry for the OmniaSecure™ defibrillation lead. The OmniaSecure lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with a Right Ventricular (RV) defibrillation coil electrode. The lead is designed for pacing, sensing, cardioversion, and defibrillation therapies, and has application for patients whom transvenous ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated.

Study Details

Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release. The LEADR PAS is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).

Key Dates

Start date
Jan 7, 2026
Status verified
May 2025
Primary completion
Sep 30, 2032
Completion
Sep 30, 2032

Study Design

Enrollment
2,000 participants (estimated)

Primary Outcome Measure

Complication Survival Rate [ Time Frame: 5 years ]

Locations (46)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35233-
COR HealthcareTorranceCalifornia90505- 5100-
Childrens Hospital ColoradoAuroraColorado80045-
Hartford HosptialHartfordConnecticut06106-
Childrens National Medical CenterWashington D.C.District of Columbia20010-
Heart Rhythm SolutionsHollywoodFlorida33021-
Cardiovascular Institute of Northwest FloridaPanama CityFlorida32405-
Heart & Vascular Institute of FloridaSafety HarborFlorida34695-
University of South Florida Health (USF)TampaFlorida33612-
WellStar Research InstituteMariettaGeorgia30060-
Deaconess Specialty PhysiciansNewburghIndiana47630-
Iowa Heart Center (West Des Moines IA)West Des MoinesIowa50266-8209-
University of Kansas Medical Center Research InstituteKansas CityKansas66160-8500-
Saint Elizabeth HealthcareEdgewoodKentucky41017-
Norton Heart and Vascular InstituteLouisvilleKentucky40205-
Sparrow Clinical Research InstituteLansingMichigan48912-
Michigan HeartYpsilantiMichigan48197-
Metropolitan Cardiology ConsultantsCoon RapidsMinnesota55433-4568-
M Health Fairview University of Minnesota Medical Center - East BankMinneapolisMinnesota55455-
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407-
North Memorial Health Heart & Vascular CenterRobbinsdaleMinnesota55422-4391-
Mayo Clinic (Rochester MN)RochesterMinnesota55905-
University Hospital (Columbia MO)ColumbiaMissouri65212-
Saint Lukes Health SystemKansas CityMissouri64111-
Washington University School of MedicineSt LouisMissouri63110-
Virtua HealthMarltonNew Jersey08053-
Presbyterian Heart GroupAlbuquerqueNew Mexico87106-
Northwell Health South Shore University HospitalBay ShoreNew York11706-
Northwell Health Huntington HospitalHuntingtonNew York11743-2787-
Long Island Jewish Medical CenterNew YorkNew York11040-
Northwell Health North Shore University HospitalNew YorkNew York10075-
Northwell Health Staten Island University HospitalStaten IslandNew York10305-3400-
Duke University Medical Center (DUMC)DurhamNorth Carolina27705-4699-
WakeMed Health & HospitalsRaleighNorth Carolina27610-
Cleveland Clinic FoundationClevelandOhio44195-
The Ohio State University Wexner Medical CenterColumbusOhio43210-1252-
Lehigh Valley Health NetworkAllentownPennsylvania18103-
Geisinger Medical CenterDanvillePennsylvania17822-9800-
Geisinger Wyoming Valley Medical CenterWilkes-BarrePennsylvania18711-
Saint Thomas Research InstituteNashvilleTennessee37205-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705-
Consultants in Cardiology (Fort Worth TX)Fort WorthTexas76104-
Heart Center of North TexasFort WorthTexas76104-
University of Virginia Medical CenterCharlottesvilleVirginia22908-
Aurora Cardiovascular ServicesMilwaukeeWisconsin53215-

Find similar trials in Birmingham, AL

By research site
The University of Alabama at Birmingham· Birmingham, ALCOR Healthcare· Torrance, CAChildrens Hospital Colorado· Aurora, COHartford Hosptial· Hartford, CTChildrens National Medical Center· Washington D.C., DCHeart Rhythm Solutions· Hollywood, FL

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