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KV-PREDICT Diagnostic Device in Patients With Heart Failure (PREDICT_HF)

2026年9月3日 更新者：KardioVis S.r.l.

Single-Centre, Interventional, Non-Invasive Clinical Study to Evaluate the Performance of the KV-PREDICT Diagnostic Medical Device in Patients With Heart Failure

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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

120

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • イタリア
    • Emilia-Romagna
      • Modena、Emilia-Romagna、イタリア、41124
        • S.C. Cardiologia, Azienda Ospedaliero-Universitaria Policlinico di Modena
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：診断
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：KV-PREDICT signal acquisition
Single group of adult heart failure patients undergoing one non-invasive KV-PREDICT signal acquisition during a scheduled outpatient visit.
デバイス：KV-PREDICT
KV-PREDICT is applied externally to the chest, over clothing (no skin contact required), during a scheduled outpatient visit. It performs a single acquisition of about 10 seconds, simultaneously recording a single-lead ECG and cardiac mechanical vibration signals. The embedded software only acquires, filters, synchronizes and transmits the signals; it produces no automated clinical output or interpretation. During the same session, an external, standalone reference pulse oximeter (photoplethysmograph), which is not connected to and not part of the investigational device, is recorded separately and used only for offline comparison during signal analysis. All signals are analyzed offline for research purposes only.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals
時間枠：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
During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Quality and suitability of KV-PREDICT recordings for extraction of mechanical gyroscopic signals
時間枠：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
During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)

二次結果の測定

結果測定
メジャーの説明
時間枠
Variability of acquired acceleration signals' amplitude across NYHA classes and left-ventricular function profiles
時間枠：During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Variability of amplitude of acceleration signals measured in mG 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
時間枠：During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Variability of amplitude of gyroscopic signals' amplitude measured in mDeg/s 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
時間枠：During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Variability of timing of acceleration signals measured in ms 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
時間枠：During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Variability of timing of gyroscopic signals measured in ms 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
時間枠：During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Number of adverse events or complaints collected during the recording sessions
During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

KardioVis S.r.l.

捜査官

  • 主任研究者：Giuseppe Boriani, MD, PhD、Azienda Ospedaliero-Universitaria di Modena

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年4月1日

研究の完了 (推定)

2027年4月1日

試験登録日

最初に提出

2026年8月25日

QC基準を満たした最初の提出物

2026年9月3日

最初の投稿 (実際)

2026年9月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月4日

QC基準を満たした最後の更新が送信されました

2026年9月3日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PREDICT-HF
  • 26-06-058156 (その他の識別子：EUDAMED (European Database on Medical Devices))

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant-level physiological signal data are proprietary and commercially sensitive to ongoing device development; the pilot, exploratory design did not provision for external data sharing. Anonymized results will be disseminated through scientific publications.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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