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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01722188
Other study ID # CD0196
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2006
Est. completion date July 2020

Study information

Verified date May 2021
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 14124
Est. completion date July 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Optim Lead Insulation Related Adverse Events

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Belgium,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival from insulation related adverse events 5 years