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Lead Registry for Optim Leads (OPTIMUM)

2021年5月7日更新者：Abbott Medical Devices

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.

研究概览

地位

完全的

条件

Optim Lead Insulation Related Adverse Events

详细说明

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.

研究类型

观察性的

注册 (实际的)

14124

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

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.

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Optim Leads

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Survival from insulation related adverse events 大体时间：5 years	5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Abbott Medical Devices

调查人员

研究主任：Grant Kim、Abbott Medical Devices

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2006年8月1日

初级完成 (实际的)

2020年7月1日

研究完成 (实际的)

2020年7月1日

研究注册日期

首次提交

2012年11月2日

首先提交符合 QC 标准的