Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
14124 participants
OBSERVATIONAL
2006-08-31
2020-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Optim Leads
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 is \< 18 years of age.
* Patient has a life expectancy of \< 2 years (malignancies)
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Grant Kim
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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Heart South Cardiovascular Group PC
Alabaster, Alabama, United States
Appalachian Cardiovascular Associates
Fort Payne, Alabama, United States
North Alabama Cardiology Center
Gadsden, Alabama, United States
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, United States
Alaska Heart Institute
Anchorage, Alaska, United States
Pima Heart Physicians, PC
Tucson, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Arkansas Cardiology
Little Rock, Arkansas, United States
*Little Rock Cardiology Clinic
Little Rock, Arkansas, United States
Northwest Cardiology
Springdale, Arkansas, United States
Westside Cardiovascular Associates
Beverly Hills, California, United States
Raymond Schaerf, MD
Burbank, 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
Mid Valley Cardiology
Fresno, California, United States
Cardiac Care Specialists
Glendale, California, United States
Glendale Memorial Hospital and Medical Center
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
William A Stellar, MD
Rancho Mirage, California, United States
Cardiac Rhythm Specialists, Inc.
Reseda, California, United States
Heart Center of Riverside
Riverside, California, United States
Mercy Medical Group Cardiology
Sacramento, 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
Sun City Cardiology Medical Center, Inc
Sun City, California, United States
Michael Burnam, MD
Tarzana, California, United States
Richard P. Cain, MD
Tarzana, California, United States
COR Healthcare Medical Associates
Torrance, California, United States
Cardiovascular Consultants
Van Nuys, California, United States
Arash Vahdat, MD
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
Harvard Park Medical
Denver, Colorado, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
Grove Hill Medical Center
New Britain, Connecticut, United States
Cardiology Associates of Fairfield County, PC
Norwalk, Connecticut, United States
Cardiac Arrhythmia Services
Boca Raton, Florida, United States
Bradenton Heart Center
Bradenton, Florida, United States
Bay Area Cardiology Associates PA
Brandon, Florida, United States
Florida Cardiology Group
Brooksville, Florida, United States
Pinellas Arrhythmia Associates
Clearwater, Florida, United States
Okaloosa Heart and Vascular
Crestview, Florida, United States
Cardiology Consultants PA
Daytona Beach, Florida, United States
The Cardiology Center, Incorporated
Delray Beach, Florida, United States
White-Wilson Medical Center - Fort Walton Beach
Fort Walton Beach, Florida, United States
The Cardiac & Vascular Institute Research Foundation, LLC
Gainesville, Florida, United States
Shands at the University of Florida
Gainesville, Florida, United States
Florida Institute For Cardiovascular Care
Hollywood, Florida, United States
Jorge Diaz, M.D., P.A.
Lake Mary, Florida, United States
Clark & Daughtrey Medical Group, PA
Lakeland, Florida, United States
Diagnostic and Interventional Cardiology
Melbourne, 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
Ram Vasudevan, MD, FACC
Ocala, Florida, United States
Central Florida Heart Center
Ocala, Florida, United States
Cardiovascular Interventions, P.A.
Orlando, Florida, United States
Mid-Florida Cardiology Specialist
Orlando, 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
Mazhar Majid, M.D.
Tamarac, Florida, United States
Heart & Vascular Center of Venice
Venice, Florida, United States
Athens Heart Center
Athens, Georgia, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, United States
St. Mary's
Athens, Georgia, United States
Piedmont Heart Institute - Buckhead Location
Atlanta, Georgia, United States
Northeast Georgia Heart Foundation
Gainesville, Georgia, United States
Gwinnet Consultants in Cardiology
Lawrenceville, Georgia, United States
Kennestone Heart Physicians
Marietta, Georgia, United States
Harbin Clinic Southeastern Cardiovascular Institute
Rome, Georgia, United States
South Georgia Cardiology PC
Valdosta, Georgia, United States
Fox Valley Cardiovascular Consultants
Aurora, Illinois, United States
Provena Saint Joseph Hospital
Elgin, Illinois, United States
MidAmerica Cardiovascular Consultants
Oak Lawn, Illinois, 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
River Cities Cardiology
Jeffersonville, Indiana, United States
Medical Consultants
Muncie, Indiana, United States
Cardiology Associates of NW Indiana
Munster, Indiana, United States
Unitypoint
Des Moines, Iowa, United States
Cumberland Cardiology
Ashland, Kentucky, United States
Cardiology Associates of Kentucky
Lexington, Kentucky, United States
Bluegrass Cardiology
Louisville, Kentucky, United States
Baptist Health Medical Group, Inc.
Madisonville, Kentucky, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States
Freedman Memorial Cardiology
Alexandria, Louisiana, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
Cardiovascular Associates
Covington, Louisiana, United States
Covington Cardiovascular Care
Covington, Louisiana, United States
St. Tammany Heart and Vascular
Covington, Louisiana, United States
Heart and Vascular Institute of LA LLC
Lacombe, Louisiana, United States
Mike Mounir MD
Lafayette, Louisiana, United States
Cardiovascular Specialists of SWLA
Lake Charles, Louisiana, United States
Imperial Health, LLP
Lake Charles, Louisiana, United States
Cardiology Center
Marrero, Louisiana, United States
Gregory C. Sampognaro Interventional Cardiology
Monroe, Louisiana, United States
Cardiology Associates Incorporated
Shreveport, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
National Naval Medical Center
Bethesda, Maryland, United States
Cardiac Associates PC
Rockville, Maryland, United States
Delmarva Heart
Salisbury, Maryland, United States
Peninsula Cardiology Associates, P.A.
Salisbury, Maryland, United States
Alan Schneider
Silver Spring, Maryland, United States
Baystate Medical Practice
Florence, Massachusetts, United States
The Cardiovascular Specialists
Hyannis, Massachusetts, 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
Cardiology and Arrhythmia Consultants P.C.
Birmingham, Michigan, United States
Regional Cardiology Associates, PLC
Grand Blanc, Michigan, United States
Academic Cardiology Associates
Rochester Hills, Michigan, United States
Heart Cardiology Consultants
Southfield, Michigan, United States
Grand Traverse Heart Associates
Traverse City, Michigan, United States
Lingareddy Devireddy, PC
Warren, Michigan, United States
St. Luke's Cardiology Associates
Duluth, Minnesota, United States
VA Medical Center Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Coast Cardiovascular Consultants
Biloxi, Mississippi, United States
Coast Cardiology Center
Gulfport, Mississippi, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Cardiovascular Consultants of Cape Girardeau Inc
Cape Girardeau, Missouri, United States
The Heart Care Group
Florissant, Missouri, United States
Cardiovascular Consultants (now St. Luke's)
Kansas City, Missouri, United States
St. Louis University Hospital
St Louis, Missouri, United States
County Cardiology, Inc.
St Louis, Missouri, United States
The Heart Health Center
St Louis, Missouri, United States
St. Louis Cardiology Consultants
St Louis, Missouri, United States
Methodist Physicians Clinic-Heart Consultants
Omaha, Nebraska, United States
Alegent Creighton Health
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Nevada Cardiology Associates
Las Vegas, Nevada, United States
Cooper University Hospital
Camden, New Jersey, United States
South Jersey Heart Group
Cherry Hill, New Jersey, United States
Hunterdon Cardiovascular Associates
Flemington, New Jersey, United States
Hamilton Cardiology Associates
Hamilton, New Jersey, United States
Atlantic Health System - Morristown Memorial Hospital
Morristown, New Jersey, United States
Monmouth Cardiology Associates, LLC
Ocean City, New Jersey, United States
Cardiology Consultants of North Jersey
Wayne, New Jersey, United States
New Jersey Cardiology Associates
West Orange, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
Adirondack Cardiology Associates
Glens Falls, New York, United States
Long Island Heart Associates
Mineola, New York, United States
Cardiac Arrhythmia and Pacemaker Center
Roslyn, New York, United States
Wayne Heart Internal Medicine
Goldsboro, North Carolina, United States
Piedmont Cardiology Associates
Hickory, North Carolina, United States
Wake Heart Associates
Raleigh, North Carolina, United States
Sanford Research
Fargo, North Dakota, United States
Altru Clinic - Main
Grand Forks, North Dakota, United States
City Cardiology Associates
Barberton, Ohio, United States
Electrophysiology & Pacing Interventionalists
Columbus, Ohio, United States
Electrophysiology and Pacing Interventionalists
Columbus, Ohio, United States
University Hospitals Elyria Medical Center
Elyria, Ohio, United States
Mercy Hospital Fairfield
Fairfield, Ohio, United States
Ohio Institute Of Cardiac Care
Springfield, Ohio, United States
Heart Care Cardiology Consultants, Inc.
Steubenville, Ohio, United States
Riverside Medical of Ohio
Steubenville, Ohio, United States
Northwest Ohio Cardiology Consultants
Toledo, Ohio, United States
Toledo Clinic
Toledo, Ohio, United States
Ohio Heart Institute
Youngstown, Ohio, United States
Cardiac Arrhythmia Associates
Youngstown, Ohio, United States
Khastgir, Terrance M.D.
Oklahoma City, Oklahoma, United States
Cardiovascular Consultants, Inc.
Tulsa, Oklahoma, United States
Abington Medical Specialists
Abington, Pennsylvania, United States
SouthWestern Pennsylvania Cardiovascular Associates
Butler, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Dubois Regional Cardiology Associates
Sandy, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 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
South Carolina Heart Center
Columbia, South Carolina, United States
Pee Dee Cardiology Associates, PA
Florence, South Carolina, United States
Piedmont Cardiology
Greenwood, South Carolina, United States
The Chattanooga Heart Institute
Chattanooga, Tennessee, United States
Mountain States Medical Group Cardiology
Johnson City, Tennessee, United States
East Tennessee Heart Consultants - Knoxville
Knoxville, Tennessee, United States
Knoxville Cardiovascular Research Group, LLC
Knoxville, Tennessee, United States
Arrhythmia Consultants, P.C.
Memphis, Tennessee, United States
Heart Rhythm Consultants
Austin, Texas, United States
Bay City Cardiology Clinic at Matagorda General Hospital
Bay City, Texas, United States
Southeast Texas Cardiology
Beaumont, Texas, United States
BCS Heart, LLP
College Station, Texas, United States
Dallas Heart Group
Dallas, Texas, United States
North Texas Heart Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Cardiology Care Consultants
El Paso, Texas, United States
Texas Heart Clinic, PA
Fort Worth, Texas, United States
Center for Cardiac Arrhythmias
Houston, Texas, United States
EP/Cardiology PA
Houston, Texas, United States
Willowbrook Cardiovascular Associates
Houston, Texas, United States
Cardiovascular Association, P.L.L.C.
Humble, Texas, United States
Texas Cardiac Center
Lubbock, Texas, United States
Permian Cardiology Associates
Midland, Texas, United States
Odessa Heart Institute, P. A.
Odessa, Texas, United States
Miguel E. Castellanos, MD
Orange, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Cardiology Clinic Of San Antonio Pa
San Antonio, Texas, United States
Brooke Army Medical Center, Division of Cardiology
San Antonio, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Cardiovascular Associates of East Texas
Tyler, Texas, United States
Victoria Heart and Vascular
Victoria, Texas, United States
Cardiovascular Associates Ltd
Chesapeake, Virginia, United States
The Cardiovascular Group
Fairfax, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Riverside Heart Specialists
Hampton, Virginia, United States
Harrisonburg Medical Associations, Inc.
Harrisonburg, Virginia, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
Hunter Holmes McGuire VAMC
Richmond, Virginia, United States
Bellevue Cardiology
Bellevue, Washington, United States
Overlake Internal Medicine Associates
Bellevue, Washington, United States
Kitsap Cardiology Consultants
Bremerton, Washington, United States
Skagit Valley Medical Center
Mount Vernon, Washington, United States
The Heart Institute at Virginia Mason
Seattle, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Kootenai Heart Clinics
Spokane, Washington, United States
Franciscan Cardiology Associates
Tacoma, Washington, United States
Franciscan Heart & Vascular Associates
Tacoma, Washington, United States
Cardiology Associates of Green Bay, Ltd.
Green Bay, Wisconsin, United States
Dean Foundation
Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
CHR Citadelle
Liège, , Belgium
Praxis Dr. med. Irtel von Brenndorff
Baden-Baden, Bad-wur, Germany
Praxis Dr. med. Markert
Gaggenau, Bad-wur, Germany
Praxis Dr. med. Behroz
Heidelberg, Bad-wur, Germany
Praxis Dr. med. Thomas Fadgyas
Dortmund, N. RHIN, Germany
Praxis Dr. med. Bernhardt
Annaberg-Buchholz, Saxony, Germany
Praxis Dr. Med. Stellmach
Chemnitz, Saxony, Germany
Praxis Frau Dr. med. Strucks
Nossen, Saxony, Germany
Klinikum Pirna GmbH Klinik für Innere Medizin II
Pirna, Saxony, Germany
Kreiskrankenhaus des Bördekreises Krankenhaus 4
Oschersleben, Sxnyanh, Germany
Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang
Erfurt, Thurgia, Germany
Helios-Klinikum Erfurt GmbH
Erfurt, Thurgia, Germany
Asklepios Klinik St. Georg
Hamberg, , Germany
Asklepios Klinik Nord Heidberg-Ochsenzoll
Hamberg, , Germany
Asklepios Klinik Altona
Hamberg, , Germany
Praxis Dr. med. Subin
Hamburg, , Germany
Countries
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Other Identifiers
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CD0196
Identifier Type: -
Identifier Source: org_study_id
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