An Observational, Prospective, Single Arm, Multi-Center Registry to Evaluate the Cordella™ Heart Failure System in New York Heart (NYHA) Class III Heart Failure Patients (PRODIGY Registry)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline to 6 month
研究概览
简要总结
This is an observational, prospective, single arm, multi-center registry to evaluate the Cordella™ Heart Failure System (CHFS) in up to 250 NYHA Class III HF patients .
详细描述
The subjects in this registry will participate in the Screening Visit, and Follow-Up Visits. After the Screening Visit, eligible subjects will be trained on at-home use of the CHFS to measure BP, HR, SpO2, weight and optional ECG.
They will be instructed to perform daily measurements of the parameters which will all be wirelessly transmitted to a secure website for review using the myCordella™ Patient Management Portal (PMP). Clinicians will be able to view Blood Pressure (BP), Heart Rate (HR), peripheral capillary oxygen saturation (SpO2), weight and Electrocardiogram (ECG) (optional) data through the myCordella™ PMP.
Subjects will return for follow up visits at 3, 6, and 12 months after enrollment or until study termination.
At Month 6, the primary endpoint will be assessed through evaluation of the subjects Quality of Life using the completed KCCQ Questions.
Assessment of secondary endpoints will be performed throughout the study duration, including evaluation of adverse events, and heart failure-related hospitalizations and medication changes. Additionally, Health Economics will be assessed per subject and per site via a detailed site questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject has given written informed consent
- •Male or female complex CCM eligible patients or equivalent and at least 18 years of age
- •Diagnosis of HF ≥ 3 months and NYHA Class III HF at the time of Screening
- •Subject fluent in English (written and oral) and with sufficient eyesight, hearing, and mental capacity to respond to the Cordella™ Heart Failure System audio/visual cues and operate the Cordella™ Heart Failure System
- •Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
- •Subject agrees:
- •that the treating Investigator is their solely complex CCM physician
- •to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up
排除标准
- •Subjects enrolled in another investigational trial.
- •Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
- •Severe illness, other than heart disease, which would limit survival to <1 year
结局指标
主要结局
Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline to 6 month
时间窗: Baseline- 6 month
The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. For brevity, only the performance characteristics of the overall summary score are presented in this discussion.The answers patients give to the KCCQ's questions are used to calculate scores in ten scales: Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Total Symptom, Social Limitation, Self-Efficacy, Quality of Life, Clinical Summary, Overall Summary
次要结局
- Percentage of device success(12 months post Enrollment)
- Heart Failure Related Medication Changes(12 months post Enrollment)
- Device/system-related complications(12 months post Enrollment)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline to 12 month(12 months post Enrollment)
- Frequency of Adverse Events(12 months post Enrollment)
- Heart Failure Hospitalizations(12 months post Enrollment)
- Health Economic Questionnaire & Cost Effectiveness Analysis(12 months post Enrollment)
- Adherence to regular myCordella™ Peripherals measurements(12 months post Enrollment)