NCT02976181已完成不适用
Registry to Improve the Adoption of Consensus Treatment Guideline (Brady MX)
Medtronic Cardiac Rhythm and Heart Failure5 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2016年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 5
- 主要终点
- Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.
研究概览
简要总结
Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that lack of awareness of treatment and diagnostics pathways result in lower number of referrals to implanters of IPG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient at least 18 years of age
- •Patient´s heart rate meets at least one of the following:
- •Patient has a sinus rate ≤ 50 OR a junctional escape rhythm no faster than 50 Patient has a history of exercise intolerance
- •Patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea OR malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia)
- •Patient (or patient´s legally authorized representative) is willing and able to sign and date written Patient Consent Form/Data Release Form
排除标准
- •Patient has recent history of blood loss
- •Patient has a medical history leading to suspicion of neurological disorder
- •Patient has a history of Chronic Atrial Fibrilation
- •Patient is enrolled or planing to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from Medtronic study manager
- •Patient is not expected to survive 12 months
- •Patient is anticipated to be unwilling or unable to comply with the clinical investigation plan
结局指标
主要结局
Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.
时间窗: 6 and 12 months
Because the study intervention was not conducted, it is not possible to compare the proportion of subjects with an SND diagnosis pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of subjects with an SND diagnosis in Phase I are reported
次要结局
- Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention(3, 6, and 15 months)
研究者
研究点 (5)
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