Phase Signal Acquisition System (PSAQ): Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,500
- 试验地点
- 33
- 主要终点
- Phase Signal Recorder Procedure
研究概览
简要总结
This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to Right Heart Cath (RHC). The repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by CorVista Health (formerly Analytics 4 Life).
详细描述
Male and Female subjects will be uniquely and consecutively enrolled into one group to support populating a repository of phase signals. Resting phase signals will be collected in all patients who meet inclusion/exclusion criteria and have signed an informed consent form. This study consists of a screening visit, resting phase signal collection (study procedure), and right heart catheterization. In this study, resting phase signals will be acquired in subjects prior to Right Heart Catheterization.
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
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
- •Patients ≥ 18 years old;
- •Scheduled to undergo right heart catheterization;
- •Ability to understand the requirements of the study and to provide written informed consent.
- •Normal Sinus Rhythm (SSR) at time of phase signal collection.
排除标准
- •Prior heart valve replacement
- •Prior lung or heart transplant
- •Infiltrative myocardial disease (amyloid, sarcoid, right ventricular dysplasia);
- •Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors;
- •Implantable Neuro-stimulators;
- •Congenital Heart Disease;
- •Pregnant or breast feeding;
- •Currently taking any Type IA, IC or III antiarrhythmics;
- •Any history of amiodarone use;
- •Clinically significant chest deformity (e.g., pectus excavatum or pectus carinatum);
- •Breast implants;
- •Neuromuscular Disease if the condition results in tremor or muscle fasciculations.
研究组 & 干预措施
Enrolled Subjects (PSR)
Patients who meet the study's entrance criteria and provide written informed consent, will undergo signal acquisition prior to their scheduled right heart catheterization (RHC) on the day of the procedure.
干预措施: CorVista Capture (Device)
结局指标
主要结局
Phase Signal Recorder Procedure
时间窗: 7 day
Resting phase signals will be collected from eligible subjects prior to Right Heart Catheterization.
次要结局
未报告次要终点