Lead Registry for Optim Leads (OPTIMUM)

Optim Lead Insulation Material Registry

This is a prospective, multi-center, actively monitored, long term data collection registry. Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a compatible market released cardia rhythm management (CRM) implantable pulse generator is eligible for enrollment into the registry.

Study Overview

• Status: Completed
• Conditions: Optim Lead Insulation Related Adverse Events

Detailed Description

Patients are enrolled in the registry up to 180 days post implantation of an Optim lead. Patients with Optim™ ICD leads and Quicksite®/Quickflex®/Quickflex® µ/Quartet® LV leads are followed indefinitely following enrollment. Patients with other Optim leads are followed for a period of 60 months after Optim™ lead implantation. The follow-up plan for this registry is based on the established follow-up practices currently used by each of the respective registry centers. Patients are followed according to the center's standard follow-up schedule.

At each office/clinic follow-up visit standard electrical measurements are collected. During system revision in a patient with either Optim™ ICD leads, Quicksite®, Quickflex®, Quickflex® µ or Quartet® LV lead, cinefluoroscopy (AP, LAO 45° or the best possible LAO view, RAO 45° or the best possible RAO view) should be performed at specific study sites. If cinefluoroscopy or chest X-ray is performed according to the site's standard of care then copies of those should be submitted.

• Study Type: Observational
• Enrollment (Actual): 14124

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHR Citadelle
• Germany
  • Hamberg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Hamberg, Germany, 22417
    • Asklepios Klinik Nord Heidberg-Ochsenzoll
  • Hamberg, Germany, 22763
    • Asklepios Klinik Altona
  • Hamburg, Germany, 20095
    • Praxis Dr. med. Subin
  • Bad-wur
    • Baden-Baden, Bad-wur, Germany, 76532
      • Praxis Dr. med. Irtel von Brenndorff
    • Gaggenau, Bad-wur, Germany, 76571
      • Praxis Dr. Med. Markert
    • Heidelberg, Bad-wur, Germany, 69123
      • Praxis Dr. med. Behroz
  • N. Rhin
    • Dortmund, N. Rhin, Germany, 44137
      • Praxis Dr. med. Thomas Fadgyas
  • Saxony
    • Annaberg-Buchholz, Saxony, Germany, 9456
      • Praxis Dr. med. Bernhardt
    • Chemnitz, Saxony, Germany, 09126
      • Praxis Dr. Med. Stellmach
    • Nossen, Saxony, Germany, 01683
      • Praxis Frau Dr. med. Strucks
    • Pirna, Saxony, Germany, 1796
      • Klinikum Pirna GmbH Klinik für Innere Medizin II
  • Sxnyanh
    • Oschersleben, Sxnyanh, Germany, 39387
      • Kreiskrankenhaus des Bördekreises Krankenhaus 4
  • Thurgia
    • Erfurt, Thurgia, Germany, 99084
      • Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang
    • Erfurt, Thurgia, Germany, 99089
      • Helios-Klinikum Erfurt GmbH
• United States
  • Alabama
    • Alabaster, Alabama, United States, 35007
      • Heart South Cardiovascular Group PC
    • Fort Payne, Alabama, United States, 35968
      • Appalachian Cardiovascular Associates
    • Gadsden, Alabama, United States, 35903
      • North Alabama Cardiology Center
    • Mobile, Alabama, United States, 36608
      • Cardiology Associates of Mobile, Inc.
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Heart Institute
  • Arizona
    • Tucson, Arizona, United States, 85723
      • Southern Arizona VA Health Care System
    • Tucson, Arizona, United States, 85712
      • Pima Heart Physicians, PC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cardiology
    • Little Rock, Arkansas, United States, 72211
      • *Little Rock Cardiology Clinic
    • Springdale, Arkansas, United States, 72764
      • Northwest Cardiology
  • California
    • Beverly Hills, California, United States, 90211
      • Westside Cardiovascular Associates
    • Burbank, California, United States, 91505
      • Raymond Schaerf, MD
    • Burlingame, California, United States, 94010
      • Mills-Peninsula Cardiovascular Specialists
    • Encino, California, United States, 91436
      • Center for Interventional Cardiology and Nephrology
    • Fresno, California, United States, 93650
      • Cardiac Institute
    • Fresno, California, United States, 93720
      • Mid Valley Cardiology
    • Glendale, California, United States, 91204
      • Glendale Memorial Hospital and Medical Center
    • Glendale, California, United States, 91203
      • Cardiac Care Specialists
    • Inglewood, California, United States, 90301
      • Apex Cardiology
    • Lakewood, California, United States, 90712
      • Kartik Thaker, MD Inc.
    • Los Alamitos, California, United States, 90720
      • Omid Vahdat M.D.
    • Los Angeles, California, United States, 90048
      • Jeffrey Goodman MD
    • Los Angeles, California, United States, 90048
      • Donna Gallik MD
    • Los Angeles, California, United States, 90067
      • Payam Yashar M.D.
    • Mission Viejo, California, United States, 92691
      • Stephen S. Ehrlich, MD
    • Murrieta, California, United States, 95263
      • Inland Valley Cardiovascular Center
    • Northridge, California, United States, 91325
      • Mehrdad Ariani MD
    • Northridge, California, United States, 91325
      • Soltera Yasuda & Associates
    • Oxnard, California, United States, 93030
      • Cabrillo Cardiology Medical Group
    • Oxnard, California, United States, 93036
      • Alejandro Garcia MD
    • Palm Springs, California, United States, 92262
      • Desert Heart Physicians
    • Pasadena, California, United States, 91105
      • Southern California Heart Specialists
    • Rancho Mirage, California, United States, 92270
      • William A Stellar, MD
    • Reseda, California, United States, 91335
      • Cardiac Rhythm Specialists, Inc.
    • Riverside, California, United States, 34232
      • Heart Center of Riverside
    • Sacramento, California, United States, 95816
      • Mercy Medical Group Cardiology
    • Salinas, California, United States, 93901
      • Salinas Valley Memorial Hospital
    • Santa Maria, California, United States, 93454
      • Bruce A. Ourieff MD
    • Sun City, California, United States, 92586
      • Sun City Cardiology Medical Center, Incorporated
    • Sun City, California, United States, 92586
      • Sun City Cardiology Medical Center, Inc
    • Tarzana, California, United States, 91356
      • Michael Burnam, MD
    • Tarzana, California, United States, 91356
      • Richard P. Cain, MD
    • Torrance, California, United States, 90505
      • COR Healthcare Medical Associates
    • Van Nuys, California, United States, 91405
      • Cardiovascular Consultants
    • Van Nuys, California, United States, 91406
      • Arash Vahdat, MD
    • Wildomar, California, United States, 92595
      • Shiva Heart Center Medical Group
    • Yuba City, California, United States, 95991
      • Feather River Cardiovascular Institute
    • Yuba City, California, United States, 95991
      • Yuba Sutter Medical Clinic
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Pikes Peak Cardiology
    • Colorado Springs, Colorado, United States, 80907
      • Penrose St. Francis Cardiology Associates PC
    • Denver, Colorado, United States, 80210
      • Harvard Park Medical
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates PC
  • Connecticut
    • New Britain, Connecticut, United States, 06052
      • Grove Hill Medical Center
    • Norwalk, Connecticut, United States, 06851
      • Cardiology Associates of Fairfield County, PC
  • Florida
    • Boca Raton, Florida, United States, 33422
      • Cardiac Arrhythmia Services
    • Bradenton, Florida, United States, 34209
      • Bradenton Heart Center
    • Brandon, Florida, United States, 33511
      • Bay Area Cardiology Associates PA
    • Brooksville, Florida, United States, 34613
      • Florida Cardiology Group
    • Clearwater, Florida, United States, 33756
      • Pinellas Arrhythmia Associates
    • Crestview, Florida, United States, 32539
      • Okaloosa Heart and Vascular
    • Daytona Beach, Florida, United States, 32114
      • Cardiology Consultants PA
    • Delray Beach, Florida, United States, 33484
      • The Cardiology Center, Incorporated
    • Fort Walton Beach, Florida, United States, 32547
      • White-Wilson Medical Center - Fort Walton Beach
    • Gainesville, Florida, United States, 32610
      • Shands at the University of Florida
    • Gainesville, Florida, United States, 32605
      • The Cardiac & Vascular Institute Research Foundation, LLC
    • Hollywood, Florida, United States, 33021
      • Florida Institute for Cardiovascular Care
    • Lake Mary, Florida, United States, 32746
      • Jorge Diaz, M.D., P.A.
    • Lakeland, Florida, United States, 33806-2098
      • Clark & Daughtrey Medical Group, PA
    • Melbourne, Florida, United States, 32901
      • Melbourne Internal Medicine Associates
    • Melbourne, Florida, United States, 32901
      • Diagnostic and Interventional Cardiology
    • Miami Beach, Florida, United States, 33140
      • Miami International Cardiology Consultants Inc
    • Ocala, Florida, United States, 34474
      • Central Florida Heart Center
    • Ocala, Florida, United States, 34471
      • Institute of Cardiovascular Research LLC
    • Ocala, Florida, United States, 34471
      • Ram Vasudevan, MD, FACC
    • Orlando, Florida, United States, 32803
      • Cardiovascular Interventions, P.A.
    • Orlando, Florida, United States, 32806
      • Mid-Florida Cardiology Specialist
    • Ormond Beach, Florida, United States, 32174
      • Cardiology Research Associates
    • Palatka, Florida, United States, 32177
      • Cardio Care Center
    • Saint Augustine, Florida, United States, 32086
      • St. Augustine Cardiology Associates
    • Sarasota, Florida, United States, 34232
      • Heart Care Research
    • Sarasota, Florida, United States, 34239
      • Sarasota Heart Center
    • Sarasota, Florida, United States, 34321
      • Sarasota Arrhythmia Institute
    • Summerfield, Florida, United States, 34491
      • Dr. Kalpesh Solanki
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
    • Tamarac, Florida, United States, 33321
      • Mazhar Majid, M.D.
    • Venice, Florida, United States, 34292
      • Heart & Vascular Center of Venice
  • Georgia
    • Athens, Georgia, United States, 30606
      • Piedmont Athens Regional Medical Center
    • Athens, Georgia, United States, 30606
      • Athens Heart Center
    • Athens, Georgia, United States, 30606
      • St. Mary's
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute - Buckhead Location
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Heart Foundation
    • Lawrenceville, Georgia, United States, 30045
      • Gwinnet Consultants in Cardiology
    • Marietta, Georgia, United States, 30060
      • Kennestone Heart Physicians
    • Rome, Georgia, United States, 30165
      • Harbin Clinic Southeastern Cardiovascular Institute
    • Valdosta, Georgia, United States, 31602
      • South Georgia Cardiology PC
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Fox Valley Cardiovascular Consultants
    • Elgin, Illinois, United States, 60123
      • Provena Saint Joseph Hospital
    • Oak Lawn, Illinois, United States, 60453
      • MidAmerica Cardiovascular Consultants
    • Rockford, Illinois, United States, 61107
      • Rockford Cardiology Associates
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Ohio Valley Heart Care
    • Hammond, Indiana, United States, 46320
      • Saint Margaret Mercy Healthcare Centers
    • Jeffersonville, Indiana, United States, 47130
      • River Cities Cardiology
    • Muncie, Indiana, United States, 47303
      • Medical Consultants
    • Munster, Indiana, United States, 46321
      • Cardiology Associates of NW Indiana
  • Iowa
    • Des Moines, Iowa, United States, 50316
      • Unitypoint
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Cumberland Cardiology
    • Lexington, Kentucky, United States, 40504
      • Cardiology Associates of Kentucky
    • Louisville, Kentucky, United States, 40215
      • Bluegrass Cardiology
    • Madisonville, Kentucky, United States, 42431
      • Baptist Health Medical Group, Inc.
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Alexandria Cardiology Clinic
    • Alexandria, Louisiana, United States, 71301
      • Freedman Memorial Cardiology
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Hospital
    • Covington, Louisiana, United States, 70433
      • Cardiovascular Associates
    • Covington, Louisiana, United States, 70433
      • Covington Cardiovascular Care
    • Covington, Louisiana, United States, 70433
      • St. Tammany Heart and Vascular
    • Lacombe, Louisiana, United States, 70445
      • Heart and Vascular Institute of LA LLC
    • Lafayette, Louisiana, United States, 70503
      • Mike Mounir MD
    • Lake Charles, Louisiana, United States, 70601
      • Imperial Health, LLP
    • Lake Charles, Louisiana, United States, 70601
      • Cardiovascular Specialists of SWLA
    • Marrero, Louisiana, United States, 70072
      • Cardiology Center
    • Monroe, Louisiana, United States, 71201
      • Gregory C. Sampognaro Interventional Cardiology
    • Shreveport, Louisiana, United States, 71105
      • Cardiology Associates Incorporated
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • National Naval Medical Center
    • Rockville, Maryland, United States, 20850
      • Cardiac Associates PC
    • Salisbury, Maryland, United States, 21804
      • Peninsula Cardiology Associates, P.A.
    • Salisbury, Maryland, United States, 21804
      • Delmarva Heart
    • Silver Spring, Maryland, United States, 20902
      • Alan Schneider
  • Massachusetts
    • Florence, Massachusetts, United States, 01062
      • Baystate Medical Practice
    • Hyannis, Massachusetts, United States, 02601
      • The Cardiovascular Specialists
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical Center
    • Worcester, Massachusetts, United States, 01608
      • Fallon Clinic
    • Worcester, Massachusetts, United States, 01608
      • Heart Rhythm Specialists of Central Massachusetts, PC
  • Michigan
    • Birmingham, Michigan, United States, 48009
      • Cardiology and Arrhythmia Consultants P.C.
    • Grand Blanc, Michigan, United States, 48439
      • Regional Cardiology Associates, PLC
    • Rochester Hills, Michigan, United States, 48307
      • Academic Cardiology Associates
    • Southfield, Michigan, United States, 48075
      • Heart Cardiology Consultants
    • Traverse City, Michigan, United States, 49684
      • Grand Traverse Heart Associates
    • Warren, Michigan, United States, 48093
      • Lingareddy Devireddy, PC
  • Minnesota
    • Duluth, Minnesota, United States, 55802
      • St. Luke's Cardiology Associates
    • Minneapolis, Minnesota, United States, 55417
      • VA Medical Center Minneapolis
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center Fairview
  • Mississippi
    • Biloxi, Mississippi, United States, 39532
      • Coast Cardiovascular Consultants
    • Gulfport, Mississippi, United States, 39503
      • Coast Cardiology Center
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703
      • Cardiovascular Consultants of Cape Girardeau Inc
    • Florissant, Missouri, United States, 63031
      • The Heart Care Group
    • Kansas City, Missouri, United States, 64111
      • Cardiovascular Consultants (now St. Luke's)
    • Saint Louis, Missouri, United States, 63110
      • St. Louis University Hospital
    • Saint Louis, Missouri, United States, 63128
      • County Cardiology, Inc.
    • Saint Louis, Missouri, United States, 63141-6835
      • The Heart Health Center
    • Saint Louis, Missouri, United States, 63146
      • St. Louis Cardiology Consultants
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68114
      • Methodist Physicians Clinic-Heart Consultants
    • Omaha, Nebraska, United States, 68124
      • Alegent Creighton Health
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Nevada Cardiology Associates
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Cherry Hill, New Jersey, United States, 08002
      • South Jersey Heart Group
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Cardiovascular Associates
    • Hamilton, New Jersey, United States, 08690
      • Hamilton Cardiology Associates
    • Morristown, New Jersey, United States, 07962
      • Atlantic Health System - Morristown Memorial Hospital
    • Ocean City, New Jersey, United States, 07712
      • Monmouth Cardiology Associates, LLC
    • Wayne, New Jersey, United States, 07470
      • Cardiology Consultants of North Jersey
    • West Orange, New Jersey, United States, 07052
      • New Jersey Cardiology Associates
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • Glens Falls, New York, United States, 12801
      • Adirondack Cardiology Associates
    • Mineola, New York, United States, 11501
      • Long Island Heart Associates
    • Roslyn, New York, United States, 11576
      • Cardiac Arrhythmia and Pacemaker Center
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Heart Internal Medicine
    • Hickory, North Carolina, United States, 28602
      • Piedmont Cardiology Associates
    • Raleigh, North Carolina, United States, 27610
      • Wake Heart Associates
  • North Dakota
    • Fargo, North Dakota, United States, 58112
      • Sanford Research
    • Grand Forks, North Dakota, United States, 58201
      • Altru Clinic - Main
  • Ohio
    • Barberton, Ohio, United States, 44203
      • City Cardiology Associates
    • Columbus, Ohio, United States, 43222
      • Electrophysiology & Pacing Interventionalists
    • Columbus, Ohio, United States, 43222
      • Electrophysiology and Pacing Interventionalists
    • Elyria, Ohio, United States, 44035
      • University Hospitals Elyria Medical Center
    • Fairfield, Ohio, United States, 45014
      • Mercy Hospital Fairfield
    • Springfield, Ohio, United States, 45504
      • Ohio Institute Of Cardiac Care
    • Steubenville, Ohio, United States, 43952
      • Heart Care Cardiology Consultants, Inc.
    • Steubenville, Ohio, United States, 43952
      • Riverside Medical of Ohio
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic
    • Toledo, Ohio, United States, 43615
      • Northwest Ohio Cardiology Consultants
    • Youngstown, Ohio, United States, 44504
      • Ohio Heart Institute
    • Youngstown, Ohio, United States, 44505
      • Cardiac Arrhythmia Associates
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Khastgir, Terrance M.D.
    • Tulsa, Oklahoma, United States, 74136
      • Cardiovascular Consultants, Inc.
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Medical Specialists
    • Butler, Pennsylvania, United States, 16001
      • SouthWestern Pennsylvania Cardiovascular Associates
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Sandy, Pennsylvania, United States, 15801
      • Dubois Regional Cardiology Associates
    • Sayre, Pennsylvania, United States, 18840
      • Donald Guthrie Foundation for Education and Research
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29403
      • Charleston Cardiology
    • Charleston, South Carolina, United States, 29407
      • Coastal Cardiology
    • Columbia, South Carolina, United States, 29204
      • South Carolina Heart Center
    • Florence, South Carolina, United States, 29506
      • Pee Dee Cardiology Associates, PA
    • Greenwood, South Carolina, United States, 29646
      • Piedmont Cardiology
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • The Chattanooga Heart Institute
    • Johnson City, Tennessee, United States, 37601
      • Mountain States Medical Group Cardiology
    • Knoxville, Tennessee, United States, 37922
      • Knoxville Cardiovascular Research Group, LLC
    • Knoxville, Tennessee, United States, 37920
      • East Tennessee Heart Consultants - Knoxville
    • Memphis, Tennessee, United States, 38104
      • Arrhythmia Consultants, P.C.
  • Texas
    • Austin, Texas, United States, 78705
      • Heart Rhythm Consultants
    • Bay City, Texas, United States, 77404
      • Bay City Cardiology Clinic at Matagorda General Hospital
    • Beaumont, Texas, United States, 77702
      • Southeast Texas Cardiology
    • College Station, Texas, United States, 77845
      • BCS Heart, LLP
    • Dallas, Texas, United States, 75390-9016
      • University of Texas Southwestern Medical Center at Dallas
    • Dallas, Texas, United States, 75230
      • Dallas Heart Group
    • Dallas, Texas, United States, 75231-3833
      • North Texas Heart Center
    • El Paso, Texas, United States, 79936
      • Cardiology Care Consultants
    • Fort Worth, Texas, United States, 76104
      • Texas Heart Clinic, PA
    • Houston, Texas, United States, 77030
      • Willowbrook Cardiovascular Associates
    • Houston, Texas, United States, 77030
      • Center for Cardiac Arrhythmias
    • Houston, Texas, United States, 77030
      • EP/Cardiology PA
    • Humble, Texas, United States, 77338
      • Cardiovascular Association, P.L.L.C.
    • Lubbock, Texas, United States, 79410
      • Texas Cardiac Center
    • Midland, Texas, United States, 79761
      • Permian Cardiology Associates
    • Odessa, Texas, United States, 79761
      • Odessa Heart Institute, P. A.
    • Orange, Texas, United States, 77630
      • Miguel E. Castellanos, MD
    • San Antonio, Texas, United States, 78201
      • South Texas Cardiovascular Consultants
    • San Antonio, Texas, United States, 78229
      • Cardiology Clinic Of San Antonio Pa
    • San Antonio, Texas, United States, 78234
      • Brooke Army Medical Center, Division of Cardiology
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
    • Tyler, Texas, United States, 75701
      • Cardiovascular Associates of East Texas
    • Victoria, Texas, United States, 77901
      • Victoria Heart and Vascular
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Cardiovascular Associates Ltd
    • Fairfax, Virginia, United States, 22031
      • The Cardiovascular Group
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Hampton, Virginia, United States, 23666
      • Riverside Heart Specialists
    • Harrisonburg, Virginia, United States, 22801
      • Harrisonburg Medical Associations, Inc.
    • Richmond, Virginia, United States, 23229
      • Virginia Cardiovascular Specialists
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VAMC
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Internal Medicine Associates
    • Bellevue, Washington, United States, 98004
      • Bellevue Cardiology
    • Bremerton, Washington, United States, 98310
      • Kitsap Cardiology Consultants
    • Mount Vernon, Washington, United States, 98274
      • Skagit Valley Medical Center
    • Seattle, Washington, United States, 98111
      • The Heart Institute at Virginia Mason
    • Spokane, Washington, United States, 99202
      • Sacred Heart Medical Center
    • Spokane, Washington, United States, 99204
      • Kootenai Heart Clinics
    • Tacoma, Washington, United States, 98405
      • Franciscan Heart & Vascular Associates
    • Tacoma, Washington, United States, 98405
      • Franciscan Cardiology Associates
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301-3528
      • Cardiology Associates of Green Bay, Ltd.
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics
    • Madison, Wisconsin, United States, 53715
      • Dean Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients implanted with market released SJM Optim lead and a compatible market released CRM implantable pulse generator (pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy device (CRT)) is eligible for enrollment into the registry.

Description

Inclusion Criteria:

• Patient has a standard indication for a CRM implantable pulse generator.
• Patient receives a market released SJM Optim lead at implant.
• Patient receives a market released CRM implantable pulse generator at implant.
• Patient is willing to provide authorization for registry participation.
• Complete device implant information, including any Optim lead related adverse event is available

Exclusion Criteria:

• Patient has medical conditions or related factors that would prevent or limit participation (including mechanical tricuspid valves, tricuspid valvular disease, and candidacy for heart transplants within 6 months).
• Patient is < 18 years of age.
• Patient has a life expectancy of < 2 years (malignancies)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Optim Leads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival from insulation related adverse events	5 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Grant Kim, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2006
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: November 2, 2012
• First Submitted That Met QC Criteria: November 2, 2012
• First Posted (Estimate): November 6, 2012

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Insulation; Optim
• Other Study ID Numbers: CD0196