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Optisure Lead Post Approval Study

2021年1月13日 更新者：Abbott Medical Devices
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.

研究概览

地位

终止

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

1735

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

  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T5H 3V9
        • Royal Alexandra Hospital
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R2H 2A6
        • St. Boniface General Hospital
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 3A7
        • QE II Health Sciences
    • Ontario
      • Kingston、Ontario、加拿大、K7L 2V7
        • Kingston General Hospital
      • London、Ontario、加拿大、N6A 5A5
        • London Health Sciences Centre
      • Scarborough、Ontario、加拿大、M1B 4Z8
        • Rouge Valley Centenary
    • Quebec
      • Montreal、Quebec、加拿大、H1T1C8
        • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
  • 德国
      • Bad Krozingen、德国、79189
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen
  • 日本
    • Kanto
      • Shinjuku-Ku、Kanto、日本、162-8666
        • Tokyo Women's Medical University
    • Osaka
      • Abeno-ku、Osaka、日本、545-8565
        • Osaka City University Hospital
    • Tochigi-ken
      • Shimotsuke-shi、Tochigi-ken、日本、329-0498
        • Jichi Medical University Hospital
  • 比利时
    • Limburg
      • Genk、Limburg、比利时、3600
        • Ziekenhuis Oost-Limburg
  • 波兰
      • Lodz、波兰
        • Mc-Tronik
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35211
        • Baptist Medical Center Princeton
    • Arizona
      • Phoenix、Arizona、美国、85018
        • Phoenix Cardiovascular Research Group
    • Arkansas
      • Jonesboro、Arkansas、美国、72401
        • St. Bernards (formerly Cardiology Associates of Northeast Arkansas)
    • California
      • Burbank、California、美国、91505
        • Raymond Schaerf, MD
      • Palm Springs、California、美国、92262
        • Desert Heart Rhythm Consultants
      • Reseda、California、美国、91335
        • Cardiac Rhythm Specialists, Inc.
      • San Diego、California、美国、92103
        • San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)
    • Florida
      • Lake Mary、Florida、美国、32746
        • Jorge Diaz, M.D. , P.A.
    • Georgia
      • Atlanta、Georgia、美国、30342
        • Northside Hospital
    • Illinois
      • Rockford、Illinois、美国、61107
        • Rockford Cardiology Associates
    • Indiana
      • Fort Wayne、Indiana、美国、46845
        • Parkview Research Center
    • Iowa
      • West Des Moines、Iowa、美国、50266
        • Iowa Heart Center
    • Kentucky
      • Edgewood、Kentucky、美国、41017
        • St. Elizabeth Medical Center - South Unit
    • Maryland
      • Salisbury、Maryland、美国、21804
        • Peninsula Cardiology Associates
    • Massachusetts
      • Leominster、Massachusetts、美国、01453
        • Mass Heart & Rhythm
    • Michigan
      • Flint、Michigan、美国、48532
        • Premier Medical Clinics
      • Grand Blanc、Michigan、美国、48439
        • Genesys Regional Medical Center
      • Traverse City、Michigan、美国、49684
        • Northern Michigan Hospital
    • Minnesota
      • Minneapolis、Minnesota、美国、55407
        • Minneapolis Heart Institute
    • Mississippi
      • Jackson、Mississippi、美国、39216
        • Jackson Heart Clinic
      • Tupelo、Mississippi、美国、38801
        • Cardiology Associates of North Mississippi
    • Nevada
      • Las Vegas、Nevada、美国、89109
        • HealthCare Partners Cardiology
    • New Jersey
      • Haddon Heights、New Jersey、美国、08035
        • Cardiovascular Associates of the Delaware Valley
      • Voorhees、New Jersey、美国、08043
        • Lourdes Cardiology Services
    • New Mexico
      • Albuquerque、New Mexico、美国、87106
        • Presbyterian Heart Group
    • New York
      • Brooklyn、New York、美国、11219
        • Maimonides Medical Center
      • Brooklyn、New York、美国、11235
        • Coney Island Hospital
      • Liverpool、New York、美国、13088
        • Cardiovascular Group of Syracuse
    • North Carolina
      • High Point、North Carolina、美国、27262
        • High Point Regional Health (formerly Carolina Cardiology Cornerstone)
      • New Bern、North Carolina、美国、28562
        • CarolinaEast Heart Center
    • Ohio
      • Cleveland、Ohio、美国、44106
        • VA Medical Center Cleveland
      • Willoughby、Ohio、美国、44094
        • Great Lakes Medical Research, LLC
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73112
        • Integris Baptist Medical Center
    • Oregon
      • Portland、Oregon、美国、97225
        • Providence Heart and Vascular Institute
    • Pennsylvania
      • Allentown、Pennsylvania、美国、18105
        • Lehigh Valley Hospital
      • Lancaster、Pennsylvania、美国、17602
        • Lancaster General Hospital
      • Newtown、Pennsylvania、美国、18940
        • Arrhythmia Institute
    • Tennessee
      • Germantown、Tennessee、美国、38138
        • The Stern Cardiovascular Foundation
    • Texas
      • Bedford、Texas、美国、76021
        • HeartPlace
      • Dallas、Texas、美国、75216
        • VA Medical Center Dallas
      • El Paso、Texas、美国、79936
        • Cardiology Care Consultants
      • Temple、Texas、美国、76508
        • Scott & White Memorial Hospital
    • Utah
      • Saint George、Utah、美国、84790
        • Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)
    • Virginia
      • Fredericksburg、Virginia、美国、22401
        • Mary Washington Hospital
      • Richmond、Virginia、美国、23229
        • Virginia Cardiovascular Specialists
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53215
        • Aurora Medical Group
  • 葡萄牙
    • Lisbon
      • Lisboa、Lisbon、葡萄牙、1649-035
        • Santa Maria Hospital

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

非概率样本

研究人群

ICD/CRT-D indicated patients

描述

Inclusion Criteria:

Eligible patients will meet all of the following:

  1. Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
  2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.
  3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
  4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

  1. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study.
  2. Have a life expectancy of less than 5 years due to any condition.

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

队列和干预

团体/队列
干预/治疗
St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
设备：St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Freedom from RV Lead Related Complications
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.

次要结果测量

结果测量
大体时间
Optisure Lead-Related Complication Rates
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.

其他结果措施

结果测量
大体时间
Optisure Lead Related Adverse Events
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
The annual hazard rate of lead electrical dysfunction
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
The annual hazard rate of externalized conductors
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
The annual hazard rate of other visual lead anomalies by each subcategory
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Prevalence of "other insulation anomalies" in "returned leads
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Time from externalized conductors to electrical dysfunction
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Time from other visual lead anomalies by each subcategory to electrical dysfunction
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other)
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Time from externalized conductors to clinical intervention
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Time from other visual lead anomalies by each subcategory to clinical intervention
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Comparison of patients with lead compromise as evidenced by imaging (includes externalized conductors and other visual lead anomalies) to those without lead compromise
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Comparison of patients with electrical dysfunction to those without electrical dysfunction.
大体时间：Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.

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)

2014年8月1日

初级完成 (实际的)

2020年6月30日

研究完成 (实际的)

2020年6月30日

研究注册日期

首次提交

2014年9月7日

首先提交符合 QC 标准的

2014年9月9日

首次发布 (估计)

2014年9月10日

研究记录更新

最后更新发布 (实际的)

2021年1月15日

上次提交的符合 QC 标准的更新

2021年1月13日

最后验证

2021年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 60045220

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

St. Jude Medical Optisure Lead的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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