LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 557
- 试验地点
- 104
- 主要终点
- Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.
研究概览
简要总结
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
详细描述
The primary objective of this study is to collect physiological measurement data and heart failure (HF) event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) systems. This study will not have pre-defined statistical endpoints. To support the primary objective, diagnostic sensor data will be compared to reference clinical testing data and heart failure decompensation events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Physiologic Sensor data will be blinded to participants and care providers. LUX-Dx ICM commercial features will be Open Label.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is currently in NYHA Class II or III.
- •For patients with LVEF >40% measured on most recent available echocardiography within the previous 12 months:
- •ONE (1) of the following echocardiography findings: LA width (diameter) >3.8 cm, LA length >5.0 cm, LA area >20 cm2, LA volume >55 ml, LA volume index >29 ml/m2, LVH defined by septal thickness or posterior wall thickness of >1.1 cm AND
- •ONE (1) of the following: Elevated BNP/NT-proBNP as defined by: BNP >100 pg/ml or NT-proBNP >300 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP >300 pg/ml or NT-proBNP >900 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
- •For patients with LVEF <40% (for MI patients, measured no less than 30 days post-MI) on most recent available echocardiography within the previous 12 months:
- •ONE (1) of the following: Elevated BNP/NT-proBNP as defined by BNP >150 pg/ml or NT-proBNP >600 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP >450 pg/ml or NT-proBNP >1800 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
- •Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app.
- •Patient is of legal age to give informed consent and is willing to participate in the trial.
排除标准
- •Patient is currently implanted with any other active electronic medical device.
- •Patient has undergone a heart transplant.
- •Patient is currently enrolled in another investigational study (excluding registries) without prior written approval from Boston Scientific.
- •Patient is known to be pregnant at the time of enrollment or plans to become pregnant during study participation.
- •Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.
研究组 & 干预措施
Treatment Arm
All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.
干预措施: Investigational LUX-Dx ICM Implant (Device)
结局指标
主要结局
Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.
时间窗: Through study completion of approximately 4.5 year
Heart Failure (HF) event is defined as: * HF Hospitalization: subject is admitted with a calendar date change with signs/symptoms of congestive heart failure (CHF) and receives unscheduled augmented HF therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy. * HF Outpatient Visit: subject has signs/symptoms of CHF, and receives unscheduled intravenous decongestive therapy in a setting that does not involve a hospitalization with a calendar date change (e.g.: ER visit, HF clinic, primary care clinic, etc.).
次要结局
未报告次要终点