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QP ExCELs: MultiPole Pacing (MPP) Sub-Study

2021年2月16日 更新者：Biotronik, Inc.
The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to demonstrate that the MPP feature is effective by converting a percentage of cardiac resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

53

阶段

  • 不适用

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

  • 美国
    • Alabama
      • Fairhope、Alabama、美国、36532
        • Thomas Hospital
    • California
      • Inglewood、California、美国、90301
        • South Bay Electrophysiology
      • Rancho Mirage、California、美国、92270
        • Eisenhower Desert Cardiology
    • District of Columbia
      • Washington、District of Columbia、美国、20010
        • MedStar Washington Hospital Center
    • Florida
      • Orlando、Florida、美国、32803
        • Florida Hospital
      • Orlando、Florida、美国、32806
        • Orlando Health Heart Institute
      • Tampa、Florida、美国、33613
        • Florida Hospital Tampa Pepin Heart Institute
    • Georgia
      • Atlanta、Georgia、美国、30309
        • Piedmont Heart Institute
    • Illinois
      • Chicago、Illinois、美国、60637
        • University of Chicago Medical Center
    • Indiana
      • Fort Wayne、Indiana、美国、46845
        • Parkview Physicians Group - Cardiology
    • Iowa
      • Iowa City、Iowa、美国、52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City、Kansas、美国、66160
        • University of Kansas Hospital
    • Kentucky
      • Lexington、Kentucky、美国、40536
        • University of Kentucky
      • Lexington、Kentucky、美国、40503
        • Baptist Health - Lexington
    • Maine
      • Bangor、Maine、美国、04401
        • Northeast Cardiology
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
      • Fall River、Massachusetts、美国、02720
        • Southcoast Health
      • Worcester、Massachusetts、美国、01655
        • University of Massachusetts Medical School
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan Hospital
      • Detroit、Michigan、美国、48202
        • Henry Ford Hospital
      • Ypsilanti、Michigan、美国、48197
        • Michigan Heart
    • Mississippi
      • Tupelo、Mississippi、美国、38801
        • Cardiology Associates of North Mississippi
    • Missouri
      • Saint Charles、Missouri、美国、63301
        • SSM Health St. Joseph Hospital - St. Charles
      • Saint Louis、Missouri、美国、63136
        • St. Louis Heart and Vascular
      • Springfield、Missouri、美国、65804
        • Mercy Clinic Cardiology
    • Montana
      • Kalispell、Montana、美国、59901
        • Glacier View Medical Research Institute, Cardiology
    • New Jersey
      • Neptune、New Jersey、美国、07753
        • Jersey Shore University Medical Center
    • New York
      • Bronx、New York、美国、10467
        • Montefiore Medical Center
      • Flushing、New York、美国、11355
        • New York Presbyterian Queens
      • New York、New York、美国、10021
        • Weill Cornell Medicine
      • New York、New York、美国、10025
        • Mt. Sinai St. Luke's Hospital
      • Valhalla、New York、美国、10595
        • Westchester Medical Center
    • North Carolina
      • Asheville、North Carolina、美国、28803
        • Asheville Cardiology Associates
      • Winston-Salem、North Carolina、美国、27157
        • Wake Forest Baptist Health Medical Center
      • Winston-Salem、North Carolina、美国、27103
        • Novant Health Winston-Salem Cardiology
    • North Dakota
      • Fargo、North Dakota、美国、58102
        • Sanford Medical Center - Fargo
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19140
        • Temple Heart and Vascular Institute
    • South Carolina
      • Greenville、South Carolina、美国、29607
        • Upstate Cardiology
    • Tennessee
      • Chattanooga、Tennessee、美国、37403
        • UT Erlanger Cardiology
    • Texas
      • Fort Worth、Texas、美国、76104
        • Fort Worth Heart
      • The Woodlands、Texas、美国、77380
        • UT Health Science Center
    • Utah
      • Salt Lake City、Utah、美国、84132
        • University of Utah Medical Center
    • Vermont
      • Burlington、Vermont、美国、05401
        • UVM Medical

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

描述

Inclusion Criteria:

  • Currently enrolled in the ongoing QP ExCELs study
  • Successfully implanted with a BIOTRONIK Ilivia 7 HF-T QP family CRT-D system, or future-marketed CRT-D system with the MPP feature. Successful implantation is defined as having at least two LV pacing vectors with a measured pacing threshold of ≤ 5.0 V @ any pulse width (allowing for a minimum 2.5 V safety margin) without phrenic nerve stimulation at the final programmed pacing output at the time of enrollment into the MPP sub-study.
  • CRT Responder Assessment classification as "Worsened" or "Unchanged"
  • Standard continuous biventricular (BiV) pacing from implant until the 6-Month QP ExCELs follow-up visit. (Implant to 3-Month QP ExCELs follow-up who qualify due to a Heart Failure (HF) hospitalization event)
  • Able to understand the nature of the sub-study and give informed consent
  • Available for an additional follow-up visit specific to the MPP sub-study at the investigational site
  • No evidence of non-compliance to their ongoing commitment in the QP ExCELs study

Exclusion Criteria:

  • Have a life expectancy of less than 6 months
  • Expected to receive heart transplantation or ventricular assist device within 6 months
  • Chronic atrial fibrillation
  • Presence of another life-threatening, underlying illness separate from their cardiac disorder
  • Received MPP pacing prior to enrolment into the MPP sub-study

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

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：MultiPole Pacing
Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
设备：MultiPole Pacing
CRT non-responders are programmed with MultiPole pacing ON.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature
大体时间：Enrollment to 6 Months

Count of participants who are classified as "Improved", where responder classification is derived from a clinical composite score (CCS) based on changes in New York Heart Association (NYHA) class, Heart Failure (HF) hospitalization, and cardiovascular death.

Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) :

  • "Improved"

    • No HF hospitalization or cardiovascular death, AND
    • NYHA class is improved

  • "Unchanged"

    • No HF hospitalization or cardiovascular death, AND
    • NYHA class is unchanged

  • "Worsened"

    • HF hospitalization or cardiovascular death has occurred, OR
    • NYHA class is worsened
Enrollment to 6 Months

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months.
大体时间：Enrollment to 6 Months
Evaluate adverse events that require additional invasive intervention to resolve specifically related to the MPP feature. These adverse events include any software issues related to MPP programming or any adverse event that occurs while MPP is enabled and that may be attributed to the use of the MPP feature. Outcome was evaluated as an adverse event free-rate (AEFR).
Enrollment to 6 Months
Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA
大体时间：Enrollment to 6 Months

Evaluate a modified CCS, determining a responder classification based on changes in NYHA class, PGA, HF hospitalization, and cardiovascular death, where the PGA will ask participantss to assess how their overall status has changed since prior to receiving CRT therapy (markedly better, better, unchanged, worse, markedly worse).

Modified responder classification (CCS + PGA) at 6 months (evaluated compared to MPP Enrollment Visit):

  • "Improved"

    • No HF hospitalization or cardiovascular death, AND
    • Neither NYHA class is worsened or PGA is worsened ("worse" or "markedly worse"), AND
    • NYHA class is improved or PGA is improved ("better" or "markedly better")

  • "Unchanged"

    • No HF hospitalization or cardiovascular death, AND
    • NYHA class is unchanged, AND
    • PGA is unchanged ("unchanged")

  • "Worsened"

    • HF hospitalization or cardiovascular death has occurred, OR
    • NYHA class is worsened or PGA is worsened ("worse" or "markedly worse")
Enrollment to 6 Months
CCS Responder Status Utilizing an Expanded Responder Classification
大体时间：Enrollment to 6 Months

Evaluate a modified CCS with an expanded responder classification where "Improved" and "Unchanged" are considered responders.

Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) :

  • "Improved"

    • No HF hospitalization or cardiovascular death, AND
    • NYHA class is improved

  • "Unchanged"

    • No HF hospitalization or cardiovascular death, AND
    • NYHA class is unchanged

  • "Worsened"

    • HF hospitalization or cardiovascular death has occurred, OR
    • NYHA class is worsened
Enrollment to 6 Months

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

Biotronik, Inc.

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)

2017年5月19日

初级完成 (实际的)

2020年1月23日

研究完成 (实际的)

2020年1月23日

研究注册日期

首次提交

2017年5月15日

首先提交符合 QC 标准的

2017年5月15日

首次发布 (实际的)

2017年5月16日

研究记录更新

最后更新发布 (实际的)

2021年3月8日

上次提交的符合 QC 标准的更新

2021年2月16日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MPP Sub-Study

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

在美国制造并从美国出口的产品

不

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.

MultiPole Pacing的临床试验

  • Medtronic Cardiac Rhythm and Heart Failure
    完全的
    获得 Performa(TM) 四极先导研究
    心脏衰竭
    美国, 加拿大, 法国, 意大利, 英国, 比利时, 西班牙, 德国, 马来西亚, 塞尔维亚, 南非, 沙特阿拉伯, 芬兰, 希腊, 澳大利亚, 荷兰, 智利, 匈牙利, 奥地利, 罗马尼亚, 瑞士, 斯洛伐克, 挪威, 以色列, 丹麦, 印度, 斯洛文尼亚

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Jordan

条件

罕见疾病

药物干预

膳食补充剂

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地点

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