Single-Centre, Interventional, Non-Invasive Clinical Study to Evaluate the Performance of the KV-PREDICT Diagnostic Medical Device in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals
研究概览
简要总结
This is a pilot, single-center, non-invasive interventional study evaluating the performance of KV-PREDICT, an investigational diagnostic medical device (Class IIa, not CE-marked), in adult patients with heart failure. During a single scheduled outpatient visit, the device is placed externally on the chest, over clothing, and records a single-lead ECG together with cardiac mechanical vibration signals for about 10 seconds. The study assesses whether the device can acquire signals of adequate quality and reproducibility to allow extraction of mechanical and electromechanical cardiac parameters (such as systolic and diastolic time intervals and the amplitudes of mechanical vibrations corresponding to the heart sounds S1-S4). The study does not aim to support clinical decisions, does not change patient management, and does not evaluate the diagnostic or predictive performance of the device. About 120 patients across NYHA functional classes I-III and different left-ventricular function profiles will be enrolled. No direct clinical benefit to participants is expected; anticipated risks are minimal given the non-invasive, brief procedure.
详细描述
Background and rationale Heart failure is a chronic condition in which periodic clinical assessment is important for follow-up. Non-invasive tools that can be used quickly during routine outpatient visits are of interest as a complement to established assessment methods. KV-PREDICT is an investigational diagnostic medical device (Class IIa, not CE-marked) developed to acquire cardiac electrical and mechanical signals non-invasively. Before any evaluation of clinical or predictive performance, it is first necessary to confirm that the device, in its current prototype configuration, can reliably acquire signals of adequate quality across patients with different degrees of heart failure severity.
Objective and nature of the study This is a single-center, non-invasive, interventional pilot study of exploratory nature. Its purpose is limited to assessing the feasibility, quality and reproducibility of the signals acquired by KV-PREDICT. The study does not evaluate the diagnostic or predictive performance of the device, is not designed to support any clinical decision, and does not modify the clinical management of participants in any way.
Study conduct Eligible patients are enrolled during a scheduled outpatient follow-up visit, after providing written informed consent. Each participant undergoes a single, brief signal-acquisition session performed with the device applied externally to the chest, over clothing, without any invasive procedure and without interfering with the standard clinical visit. No dedicated follow-up visits are required for the purposes of this study.
Data handling and analysis The acquired signals are used exclusively for research purposes and are analyzed offline, after the acquisition session, outside the clinical setting. No automated interpretation or clinical output is generated by the device during the visit. Analyses are descriptive and exploratory, consistent with the pilot nature of the study.
Expected value and risks No direct clinical benefit to individual participants is expected. Because the procedure is non-invasive and brief, the anticipated risks and burden for participants are minimal. The results are intended to inform the subsequent development of the device.
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
- •Age 18 years or older
- •Clinical diagnosis of heart failure
- •NYHA functional class I, II, or III
- •Able to understand the study information and provide written informed consent
- •Attending a scheduled outpatient follow-up visit at the site
排除标准
- •Acute clinical instability at the time of the visit
- •Conditions that, in the investigator's judgment, could interfere with correct performance of the acquisition procedure
- •Inability to provide valid informed consent
- •Concurrent participation in other studies that could interfere with the aims of this investigation
研究组 & 干预措施
KV-PREDICT signal acquisition
Single group of adult heart failure patients undergoing one non-invasive KV-PREDICT signal acquisition during a scheduled outpatient visit.
干预措施: KV-PREDICT (Device)
结局指标
主要结局
Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals
时间窗: During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Number and corresponding percentage of technically valid and processable acceleration signal acquisitions measured in mG, across patients with different heart-failure severity
Quality and suitability of KV-PREDICT recordings for extraction of mechanical gyroscopic signals
时间窗: During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Number and corresponding percentage of technically valid and processable gyroscopic signal acquisitions measured in mDeg/s, across patients with different heart-failure severity
次要结局
- Variability of acquired acceleration signals' amplitude across NYHA classes and left-ventricular function profiles(During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording))
- Variability of acquired gyroscopic signals' amplitude across NYHA classes and left-ventricular function profiles(During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording))
- Variability of acquired acceleration signals' timing across NYHA classes and left-ventricular function profiles(During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording))
- Variability of acquired gyroscopic signals' timing across NYHA classes and left-ventricular function profiles(During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording))
- Adverse events or complaints related to the procedure for data acquisition(During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording))