Heart Failure / KV-PREDICT · Interventional Study

KV-PREDICT Diagnostic Device in Patients With Heart Failure

ClinicalTrials.gov · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned pilot feasibility study of an investigational, non-CE-marked Class IIa diagnostic device (KV-PREDICT) designed to acquire cardiac mechanical vibration signals in heart failure patients. The study will assess signal quality and reproducibility only, not diagnostic accuracy or clinical utility, and is not yet recruiting. No results are available from this registry record.

What was studied

Interventional, Single Group, Open label, Diagnostic purpose. Heart Failure; age from 18 Years. Intervention: KV-PREDICT signal acquisition. n = 120. 1 site: Italy.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This study does not aim to support clinical decisions or change patient management. Professionals should await results demonstrating that the device can reliably acquire and extract cardiac parameters before considering any clinical application.

Plain-language summary

Pilot, single-center, non-invasive feasibility study of an unvalidated diagnostic device; no clinical outcomes, diagnostic accuracy, or predictive performance evaluated; enrollment not yet recruiting.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals (assessed at During the single signal-acquisition session at the scheduled study visit (abou…); Quality and suitability of KV-PREDICT recordings for extraction of mechanical gyroscopic signals (assessed at During the single signal-acquisition session at the scheduled study visit (abou…)

DesignInterventional, Single Group, Open label, Diagnostic purpose

PopulationHeart Failure; age from 18 Years

Sample size120

InterventionKV-PREDICT signal acquisition

Setting1 site: Italy

Reported figures

Quoted from the source exactly as published.

Planned enrollment120

Primary outcome measure 1Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals during single signal-acquisition session (~10 seconds)

Primary outcome measure 2Quality and suitability of KV-PREDICT recordings for extraction of mechanical gyroscopic signals during single signal-acquisition session (~10 seconds)

Recording durationapproximately 10 seconds

Clinical bottom line

Caveats

This is a registry record with no published results; outcomes are not yet reported.
Study is non-invasive feasibility-focused and does not evaluate diagnostic accuracy, predictive value, or clinical utility.
Single-center design with no comparator or control group; generalizability unknown.
Device is not CE-marked and is investigational (Class IIa); regulatory status and clinical validation pathway not stated.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Pilot, single-center design with no control arm or comparator.

Directness

limited

Measures signal quality and reproducibility only; does not evaluate diagnostic or predictive performance.

Consistency

insufficient

Single-center study; no comparator or external validation data provided.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or bias mitigation strategies.

Sample adequacy

limited

Estimated 120 participants for a pilot feasibility study; no power calculation stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07805213). This is a study registration, not published results. Lead sponsor: KardioVis S.r.l.. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DEVICE: KV-PREDICT. Primary outcome measures: Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals , 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 , During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording). Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

KardioVis S.r.l.Heart FailureNCT07805213KV-PREDICT