CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements (CONFIRM)
Comparison of in Office Interrogation vs. Remote Measurements
The primary objective of this study is to evaluate the efficacy of the automated data collection in the Zephyr device as compared to manual testing results for atrial and ventricular pacing thresholds. The secondary objectives include: to compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient; to compare the accuracy of the automated device test results to manual testing results; evaluate the percentage of patients who are recommended for ACapTM Confirm utilization.
The Primary Hypotheses are:
- The values reported from ACapTM Confirm will be within 0.125 V of the value that is obtained manually in clinic.
- The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value that is obtained manually in clinic.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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British Columbia
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Kelowna、British Columbia、加拿大
- Kelowna General Hospital
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Vancouver、British Columbia、加拿大、V7L2P7
- North Shore Heart Group
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Ontario
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Brampton、Ontario、加拿大、L6R 3J7
- William Osler Health Centre
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Peterborough、Ontario、加拿大
- Peterborough Regional
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Quebec
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Québec、Quebec、加拿大、G1J 1Z6
- Clinique de Cardiologie Desilets
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Québec、Quebec、加拿大、G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients have been implanted with their device ~ 6 months prior
- Patients must have their device evaluated at the enrolling center.
- Patients must be able to comply with the regular routine follow-up schedule of the enrolling clinic.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
- Patients age 18 or greater.
Exclusion Criteria:
- Patient has a unipolar atrial lead implanted.
- Patients who are or may potentially be pregnant.
- Patients with persistent AF.
- Less than 1 year life expectancy
学习计划
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 |
|---|---|
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Pacemaker patients
Patients who are implanted with a SJM Zephyr™ DR device for a standard pacing indication will be eligible
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The testing algorithms allow the device to display threshold measurements at time of device interrogation.
These will be evaluated against manual testing results.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds
大体时间：12 and 18 months post-implant
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12 and 18 months post-implant
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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To compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient.
大体时间：12 and 18 months post-implant
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12 and 18 months post-implant
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- SJM LV001
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.
VentricularAutoCaptureTM & ACapTM Confirm的临床试验
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Sparrow Clinical Research InstituteAbbott完全的
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Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Abbott Medical Devices完全的
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University Hospital Inselspital, BerneAbbott; University Hospital, Zürich; Bangerter-Rhyner Stiftung招聘中