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临床试验/NCT03405740
NCT03405740已完成不适用

Virtual Integrated Reliable Transformative User-driven E-health System for Implantable Cardioverter Defibrillators

Ratika Parkash12 个研究点 分布在 1 个国家目标入组 1,115 人开始时间: 2020年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,115
试验地点
12
主要终点
Time to major adverse cardiac event (primary safety outcome)

研究概览

简要总结

This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management with VIRTUES versus usual care, and will be stratified by RemoteView vs no RemoteView utilization, as well as by center.

详细描述

Remote monitoring (RM) has been in use for over a decade and is now used in a blended system of in clinic visits and RM to provide CIED follow up. Prior studies have focused on this blended model of follow up. In this study, we propose a paradigm shift in CIED follow up care that is fully remote, supported by a patient-centered communication system permitting patients to have greater understanding of their CIED and its function. Patients would not have to leave their own communities to obtain state-of-the art care for their cardiac condition or their CIED. Given the burgeoning use of CIEDs (ICDs and PMs), the aging population and particularly in Canada where 19% of the inhabitants are in communities classified as 'rural', many have long distances to travel to reach a health care facility, it is of the utmost importance to take full advantage of available and developing technologies to improve CIED follow up beyond current recommendations. During the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated. New technology has become available that not only permits surveillance, but also permits communication back to the patient, and their respective providers regarding the status of these devices. The combination of technologies will result in a total care of CIEDs termed Remote Patient Management - CIED (RPM-CIED). The incorporation of enhanced monitoring capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team ('spokes') and no longer require travel to the specialized device clinics ('hubs') for follow-up. It creates capacity in the specialized centers to focus exclusively on the problematic cases by removing the need for routine checks.

There are two avenues of new technology that will be used in this study:

  1. Remote View: this secure, web-based portal facilitates a virtual view of the device programming by the specialist in real-time while the patient is in their local clinic, thus avoiding patient travel to the specialized clinic (hub).
  2. VIRTUES (Virtual Integrated Reliable Transformative User-driven E-health System): this portal has been developed by the Cardiac Arrhythmia Network of Canada to allow the patient to receive reports from the remote transmissions of their device.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a Medtronic, Abbott or Boston Scientific defibrillator/CRT-D capable of remote monitoring with Carelink, Merlin or Latitude.
  • Able to provide consent.
  • Age >/= 18 years

排除标准

  • No family physician or general practitioner
  • Inability to be referred to a specialist
  • Currently followed more than every 6 months by a Heart Function Clinic
  • Participation in another randomized clinical trial that impacts outcome
  • Unreliable automated capture verification by device in pacemaker dependent patient

研究组 & 干预措施

Remote Patient Management

Active Comparator

Patients will be followed by remote monitoring only.

干预措施: Remote Patient Management (Device)

Standard of Care

Placebo Comparator

Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site.

干预措施: Standard of Care (Device)

结局指标

主要结局

Time to major adverse cardiac event (primary safety outcome)

时间窗: 18 months

Time to a major adverse event, including: death, stroke, hospitalization for complications relating to the device system, cardiovascular hospitalization, syncope, device-related Emergency Department visits.

Time to a device-detected event (primary efficacy outcome)

时间窗: 18 months

The response time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular disease progression, and device issues with remote patient management as compared to standard of care

次要结局

  • Medication Compliance(18 Months)
  • Minimum programming compliance(18 months)
  • Number of clinical events leading to a change in medication(18 months)
  • Inappropriate ICD shocks(18 months)
  • Appropriate ICD shocks(18 months)
  • Time to detection of ventricular arrhythmia events(18 months)
  • Detection of atrial high-rate episodes(18 months)
  • Number of Cardiovascular-related ER visits(18 months)
  • Number of Device-Related ER visits(18 Months)
  • Rate of syncope(18 months)
  • Cost effectiveness(18 months)

研究者

发起方
Ratika Parkash
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ratika Parkash

Staff Electrophysiologist

Nova Scotia Health Authority

研究点 (12)

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