Lead Registry for Optim Leads
- Conditions
- Optim Lead Insulation Related Adverse Events
- Registration Number
- NCT01722188
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14124
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival from insulation related adverse events 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (261)
Electrophysiology and Pacing Interventionalists
🇺🇸Columbus, Ohio, United States
Center for Cardiac Arrhythmias
🇺🇸Houston, Texas, United States
The Heart Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
Heart South Cardiovascular Group PC
🇺🇸Alabaster, Alabama, United States
North Alabama Cardiology Center
🇺🇸Gadsden, Alabama, United States
Pima Heart Physicians, PC
🇺🇸Tucson, Arizona, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
*Little Rock Cardiology Clinic
🇺🇸Little Rock, Arkansas, United States
Arkansas Cardiology
🇺🇸Little Rock, Arkansas, United States
Alaska Heart Institute
🇺🇸Anchorage, Alaska, United States
Northwest Cardiology
🇺🇸Springdale, Arkansas, United States
Raymond Schaerf, MD
🇺🇸Burbank, California, United States
Westside Cardiovascular Associates
🇺🇸Beverly Hills, California, United States
Mills-Peninsula Cardiovascular Specialists
🇺🇸Burlingame, California, United States
Center for Interventional Cardiology and Nephrology
🇺🇸Encino, California, United States
Cardiac Institute
🇺🇸Fresno, California, United States
Glendale Memorial Hospital and Medical Center
🇺🇸Glendale, California, United States
Mid Valley Cardiology
🇺🇸Fresno, California, United States
Cardiac Care Specialists
🇺🇸Glendale, California, United States
Apex Cardiology
🇺🇸Inglewood, California, United States
Kartik Thaker, MD Inc.
🇺🇸Lakewood, California, United States
Omid Vahdat M.D.
🇺🇸Los Alamitos, California, United States
Donna Gallik MD
🇺🇸Los Angeles, California, United States
Jeffrey Goodman MD
🇺🇸Los Angeles, California, United States
Payam Yashar M.D.
🇺🇸Los Angeles, California, United States
Stephen S. Ehrlich, MD
🇺🇸Mission Viejo, California, United States
Inland Valley Cardiovascular Center
🇺🇸Murrieta, California, United States
Mehrdad Ariani MD
🇺🇸Northridge, California, United States
Soltera Yasuda & Associates
🇺🇸Northridge, California, United States
Cabrillo Cardiology Medical Group
🇺🇸Oxnard, California, United States
Alejandro Garcia MD
🇺🇸Oxnard, California, United States
Desert Heart Physicians
🇺🇸Palm Springs, California, United States
Southern California Heart Specialists
🇺🇸Pasadena, California, United States
Heart Center of Riverside
🇺🇸Riverside, California, United States
William A Stellar, MD
🇺🇸Rancho Mirage, California, United States
Cardiac Rhythm Specialists, Inc.
🇺🇸Reseda, California, United States
Salinas Valley Memorial Hospital
🇺🇸Salinas, California, United States
Bruce A. Ourieff MD
🇺🇸Santa Maria, California, United States
Sun City Cardiology Medical Center, Incorporated
🇺🇸Sun City, California, United States
Richard P. Cain, MD
🇺🇸Tarzana, California, United States
Sun City Cardiology Medical Center, Inc
🇺🇸Sun City, California, United States
Michael Burnam, MD
🇺🇸Tarzana, California, United States
Arash Vahdat, MD
🇺🇸Van Nuys, California, United States
COR Healthcare Medical Associates
🇺🇸Torrance, California, United States
Cardiovascular Consultants
🇺🇸Van Nuys, California, United States
Shiva Heart Center Medical Group
🇺🇸Wildomar, California, United States
Feather River Cardiovascular Institute
🇺🇸Yuba City, California, United States
Yuba Sutter Medical Clinic
🇺🇸Yuba City, California, United States
Penrose St. Francis Cardiology Associates PC
🇺🇸Colorado Springs, Colorado, United States
Pikes Peak Cardiology
🇺🇸Colorado Springs, Colorado, United States
Grove Hill Medical Center
🇺🇸New Britain, Connecticut, United States
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
Cardiology Associates of Fairfield County, PC
🇺🇸Norwalk, Connecticut, United States
Florida Cardiology Group
🇺🇸Brooksville, Florida, United States
Cardiac Arrhythmia Services
🇺🇸Boca Raton, Florida, United States
Bay Area Cardiology Associates PA
🇺🇸Brandon, Florida, United States
White-Wilson Medical Center - Fort Walton Beach
🇺🇸Fort Walton Beach, Florida, United States
Okaloosa Heart and Vascular
🇺🇸Crestview, Florida, United States
Bradenton Heart Center
🇺🇸Bradenton, Florida, United States
Pinellas Arrhythmia Associates
🇺🇸Clearwater, Florida, United States
The Cardiology Center, Incorporated
🇺🇸Delray Beach, Florida, United States
Florida Institute For Cardiovascular Care
🇺🇸Hollywood, Florida, United States
Jorge Diaz, M.D., P.A.
🇺🇸Lake Mary, Florida, United States
Diagnostic and Interventional Cardiology
🇺🇸Melbourne, Florida, United States
Clark & Daughtrey Medical Group, PA
🇺🇸Lakeland, Florida, United States
Melbourne Internal Medicine Associates
🇺🇸Melbourne, Florida, United States
Miami International Cardiology Consultants Inc
🇺🇸Miami Beach, Florida, United States
Institute of Cardiovascular Research LLC
🇺🇸Ocala, Florida, United States
Central Florida Heart Center
🇺🇸Ocala, Florida, United States
Ram Vasudevan, MD, FACC
🇺🇸Ocala, Florida, United States
Cardiology Research Associates
🇺🇸Ormond Beach, Florida, United States
Cardio Care Center
🇺🇸Palatka, Florida, United States
St. Augustine Cardiology Associates
🇺🇸Saint Augustine, Florida, United States
Heart Care Research
🇺🇸Sarasota, Florida, United States
Sarasota Heart Center
🇺🇸Sarasota, Florida, United States
Sarasota Arrhythmia Institute
🇺🇸Sarasota, Florida, United States
Dr. Kalpesh Solanki
🇺🇸Summerfield, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Heart & Vascular Center of Venice
🇺🇸Venice, Florida, United States
Mazhar Majid, M.D.
🇺🇸Tamarac, Florida, United States
Piedmont Athens Regional Medical Center
🇺🇸Athens, Georgia, United States
St. Mary's
🇺🇸Athens, Georgia, United States
Northeast Georgia Heart Foundation
🇺🇸Gainesville, Georgia, United States
Piedmont Heart Institute - Buckhead Location
🇺🇸Atlanta, Georgia, United States
Kennestone Heart Physicians
🇺🇸Marietta, Georgia, United States
Harbin Clinic Southeastern Cardiovascular Institute
🇺🇸Rome, Georgia, United States
Fox Valley Cardiovascular Consultants
🇺🇸Aurora, Illinois, United States
Riverside Medical of Ohio
🇺🇸Steubenville, Ohio, United States
Abington Medical Specialists
🇺🇸Abington, Pennsylvania, United States
VA Medical Center Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
Brooke Army Medical Center, Division of Cardiology
🇺🇸San Antonio, Texas, United States
Harvard Park Medical
🇺🇸Denver, Colorado, United States
Asklepios Klinik St. Georg
🇩🇪Hamberg, Germany
Praxis Dr. med. Subin
🇩🇪Hamburg, Germany
Appalachian Cardiovascular Associates
🇺🇸Fort Payne, Alabama, United States
Cardiology Associates of NW Indiana
🇺🇸Munster, Indiana, United States
Delmarva Heart
🇺🇸Salisbury, Maryland, United States
MidAmerica Cardiovascular Consultants
🇺🇸Oak Lawn, Illinois, United States
Our Lady of the Lake Hospital
🇺🇸Baton Rouge, Louisiana, United States
Peninsula Cardiology Associates, P.A.
🇺🇸Salisbury, Maryland, United States
Rockford Cardiology Associates
🇺🇸Rockford, Illinois, United States
Ohio Valley Heart Care
🇺🇸Evansville, Indiana, United States
Saint Margaret Mercy Healthcare Centers
🇺🇸Hammond, Indiana, United States
Alan Schneider
🇺🇸Silver Spring, Maryland, United States
The Heart Health Center
🇺🇸Saint Louis, Missouri, United States
National Naval Medical Center
🇺🇸Bethesda, Maryland, United States
Fallon Clinic
🇺🇸Worcester, Massachusetts, United States
Heart Rhythm Specialists of Central Massachusetts, PC
🇺🇸Worcester, Massachusetts, United States
University of Massachusetts Medical Center
🇺🇸Worcester, Massachusetts, United States
Lingareddy Devireddy, PC
🇺🇸Warren, Michigan, United States
Cardiac Associates PC
🇺🇸Rockville, Maryland, United States
Cardiology and Arrhythmia Consultants P.C.
🇺🇸Birmingham, Michigan, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
St. Luke's Cardiology Associates
🇺🇸Duluth, Minnesota, United States
The Cardiovascular Specialists
🇺🇸Hyannis, Massachusetts, United States
Grand Traverse Heart Associates
🇺🇸Traverse City, Michigan, United States
Nevada Cardiology Associates
🇺🇸Las Vegas, Nevada, United States
Alegent Creighton Health
🇺🇸Omaha, Nebraska, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
New Jersey Cardiology Associates
🇺🇸West Orange, New Jersey, United States
Sanford Research
🇺🇸Fargo, North Dakota, United States
Kootenai Heart Clinics
🇺🇸Spokane, Washington, United States
Hamilton Cardiology Associates
🇺🇸Hamilton, New Jersey, United States
Donald Guthrie Foundation for Education and Research
🇺🇸Sayre, Pennsylvania, United States
South Jersey Heart Group
🇺🇸Cherry Hill, New Jersey, United States
Atlantic Health System - Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Dallas Heart Group
🇺🇸Dallas, Texas, United States
Cardiac Arrhythmia Associates
🇺🇸Youngstown, Ohio, United States
Cardiovascular Consultants, Inc.
🇺🇸Tulsa, Oklahoma, United States
Texas Heart Clinic, PA
🇺🇸Fort Worth, Texas, United States
Asklepios Klinik Nord Heidberg-Ochsenzoll
🇩🇪Hamberg, Germany
Pee Dee Cardiology Associates, PA
🇺🇸Florence, South Carolina, United States
Praxis Dr. med. Bernhardt
🇩🇪Annaberg-Buchholz, Saxony, Germany
Klinikum Pirna GmbH Klinik für Innere Medizin II
🇩🇪Pirna, Saxony, Germany
Praxis Dr. med. Markert
🇩🇪Gaggenau, Bad-wur, Germany
CHR Citadelle
🇧🇪Liège, Belgium
South Texas Cardiovascular Consultants
🇺🇸San Antonio, Texas, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Miguel E. Castellanos, MD
🇺🇸Orange, Texas, United States
Asklepios Klinik Altona
🇩🇪Hamberg, Germany
Willowbrook Cardiovascular Associates
🇺🇸Houston, Texas, United States
Cardiology Care Consultants
🇺🇸El Paso, Texas, United States
Praxis Dr. Med. Stellmach
🇩🇪Chemnitz, Saxony, Germany
The Cardiovascular Group
🇺🇸Fairfax, Virginia, United States
Victoria Heart and Vascular
🇺🇸Victoria, Texas, United States
Riverside Heart Specialists
🇺🇸Hampton, Virginia, United States
Franciscan Cardiology Associates
🇺🇸Tacoma, Washington, United States
Praxis Frau Dr. med. Strucks
🇩🇪Nossen, Saxony, Germany
Praxis Dr. med. Behroz
🇩🇪Heidelberg, Bad-wur, Germany
Helios-Klinikum Erfurt GmbH
🇩🇪Erfurt, Thurgia, Germany
Cardiovascular Consultants of Cape Girardeau Inc
🇺🇸Cape Girardeau, Missouri, United States
St. Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
County Cardiology, Inc.
🇺🇸Saint Louis, Missouri, United States
Cardiology Associates of Mobile, Inc.
🇺🇸Mobile, Alabama, United States
Methodist Physicians Clinic-Heart Consultants
🇺🇸Omaha, Nebraska, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Khastgir, Terrance M.D.
🇺🇸Oklahoma City, Oklahoma, United States
Arrhythmia Consultants, P.C.
🇺🇸Memphis, Tennessee, United States
SouthWestern Pennsylvania Cardiovascular Associates
🇺🇸Butler, Pennsylvania, United States
Wake Heart Associates
🇺🇸Raleigh, North Carolina, United States
Alexandria Cardiology Clinic
🇺🇸Alexandria, Louisiana, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Skagit Valley Medical Center
🇺🇸Mount Vernon, Washington, United States
Cardiovascular Specialists of SWLA
🇺🇸Lake Charles, Louisiana, United States
Baptist Health Medical Group, Inc.
🇺🇸Madisonville, Kentucky, United States
North Texas Heart Center
🇺🇸Dallas, Texas, United States
Cardiovascular Association, P.L.L.C.
🇺🇸Humble, Texas, United States
Cardiology Clinic Of San Antonio Pa
🇺🇸San Antonio, Texas, United States
Odessa Heart Institute, P. A.
🇺🇸Odessa, Texas, United States
Cardiology Consultants PA
🇺🇸Daytona Beach, Florida, United States
Heart Cardiology Consultants
🇺🇸Southfield, Michigan, United States
Cardiovascular Associates Ltd
🇺🇸Chesapeake, Virginia, United States
Heart and Vascular Institute of LA LLC
🇺🇸Lacombe, Louisiana, United States
Medical Consultants
🇺🇸Muncie, Indiana, United States
Gwinnet Consultants in Cardiology
🇺🇸Lawrenceville, Georgia, United States
Mike Mounir MD
🇺🇸Lafayette, Louisiana, United States
Cardiovascular Associates
🇺🇸Covington, Louisiana, United States
Covington Cardiovascular Care
🇺🇸Covington, Louisiana, United States
Cardiology Associates Incorporated
🇺🇸Shreveport, Louisiana, United States
Freedman Memorial Cardiology
🇺🇸Alexandria, Louisiana, United States
Hunterdon Cardiovascular Associates
🇺🇸Flemington, New Jersey, United States
St. Tammany Heart and Vascular
🇺🇸Covington, Louisiana, United States
Imperial Health, LLP
🇺🇸Lake Charles, Louisiana, United States
Gregory C. Sampognaro Interventional Cardiology
🇺🇸Monroe, Louisiana, United States
Cardiology Center
🇺🇸Marrero, Louisiana, United States
Regional Cardiology Associates, PLC
🇺🇸Grand Blanc, Michigan, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Baystate Medical Practice
🇺🇸Florence, Massachusetts, United States
Coast Cardiology Center
🇺🇸Gulfport, Mississippi, United States
The Heart Care Group
🇺🇸Florissant, Missouri, United States
Coast Cardiovascular Consultants
🇺🇸Biloxi, Mississippi, United States
Adirondack Cardiology Associates
🇺🇸Glens Falls, New York, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Wayne Heart Internal Medicine
🇺🇸Goldsboro, North Carolina, United States
Cardiology Consultants of North Jersey
🇺🇸Wayne, New Jersey, United States
Mercy Hospital Fairfield
🇺🇸Fairfield, Ohio, United States
Ohio Heart Institute
🇺🇸Youngstown, Ohio, United States
Long Island Heart Associates
🇺🇸Mineola, New York, United States
Heart Care Cardiology Consultants, Inc.
🇺🇸Steubenville, Ohio, United States
Cardiac Arrhythmia and Pacemaker Center
🇺🇸Roslyn, New York, United States
City Cardiology Associates
🇺🇸Barberton, Ohio, United States
Electrophysiology & Pacing Interventionalists
🇺🇸Columbus, Ohio, United States
Ohio Institute Of Cardiac Care
🇺🇸Springfield, Ohio, United States
Altru Clinic - Main
🇺🇸Grand Forks, North Dakota, United States
Dubois Regional Cardiology Associates
🇺🇸Sandy, Pennsylvania, United States
Piedmont Cardiology
🇺🇸Greenwood, South Carolina, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
BCS Heart, LLP
🇺🇸College Station, Texas, United States
Mountain States Medical Group Cardiology
🇺🇸Johnson City, Tennessee, United States
The Chattanooga Heart Institute
🇺🇸Chattanooga, Tennessee, United States
East Tennessee Heart Consultants - Knoxville
🇺🇸Knoxville, Tennessee, United States
Bay City Cardiology Clinic at Matagorda General Hospital
🇺🇸Bay City, Texas, United States
EP/Cardiology PA
🇺🇸Houston, Texas, United States
Permian Cardiology Associates
🇺🇸Midland, Texas, United States
Knoxville Cardiovascular Research Group, LLC
🇺🇸Knoxville, Tennessee, United States
Cardiovascular Associates of East Texas
🇺🇸Tyler, Texas, United States
Southeast Texas Cardiology
🇺🇸Beaumont, Texas, United States
Texas Cardiac Center
🇺🇸Lubbock, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Bellevue Cardiology
🇺🇸Bellevue, Washington, United States
Kitsap Cardiology Consultants
🇺🇸Bremerton, Washington, United States
Cardiology Associates of Green Bay, Ltd.
🇺🇸Green Bay, Wisconsin, United States
Harrisonburg Medical Associations, Inc.
🇺🇸Harrisonburg, Virginia, United States
Overlake Internal Medicine Associates
🇺🇸Bellevue, Washington, United States
Franciscan Heart & Vascular Associates
🇺🇸Tacoma, Washington, United States
Praxis Dr. med. Irtel von Brenndorff
🇩🇪Baden-Baden, Bad-wur, Germany
Praxis Dr. med. Thomas Fadgyas
🇩🇪Dortmund, N. Rhin, Germany
Kreiskrankenhaus des Bördekreises Krankenhaus 4
🇩🇪Oschersleben, Sxnyanh, Germany
Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang
🇩🇪Erfurt, Thurgia, Germany
Mercy Medical Group Cardiology
🇺🇸Sacramento, California, United States
Cardiovascular Interventions, P.A.
🇺🇸Orlando, Florida, United States
Mid-Florida Cardiology Specialist
🇺🇸Orlando, Florida, United States
Cardiovascular Consultants (now St. Luke's)
🇺🇸Kansas City, Missouri, United States
Bluegrass Cardiology
🇺🇸Louisville, Kentucky, United States
Charleston Cardiology
🇺🇸Charleston, South Carolina, United States
Coastal Cardiology
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Hunter Holmes McGuire VAMC
🇺🇸Richmond, Virginia, United States
The Cardiac & Vascular Institute Research Foundation, LLC
🇺🇸Gainesville, Florida, United States
Shands at the University of Florida
🇺🇸Gainesville, Florida, United States
Unitypoint
🇺🇸Des Moines, Iowa, United States
Cardiology Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Heart Rhythm Consultants
🇺🇸Austin, Texas, United States
Virginia Cardiovascular Specialists
🇺🇸Richmond, Virginia, United States
Dean Foundation
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Athens Heart Center
🇺🇸Athens, Georgia, United States
River Cities Cardiology
🇺🇸Jeffersonville, Indiana, United States
Cumberland Cardiology
🇺🇸Ashland, Kentucky, United States
Northwest Ohio Cardiology Consultants
🇺🇸Toledo, Ohio, United States
Provena Saint Joseph Hospital
🇺🇸Elgin, Illinois, United States
Monmouth Cardiology Associates, LLC
🇺🇸Ocean City, New Jersey, United States
Piedmont Cardiology Associates
🇺🇸Hickory, North Carolina, United States
University Hospitals Elyria Medical Center
🇺🇸Elyria, Ohio, United States
Toledo Clinic
🇺🇸Toledo, Ohio, United States
Academic Cardiology Associates
🇺🇸Rochester Hills, Michigan, United States
South Georgia Cardiology PC
🇺🇸Valdosta, Georgia, United States
St. Louis Cardiology Consultants
🇺🇸Saint Louis, Missouri, United States