Heart FailurePREDICT_HFNCT07805213
KV-PREDICT Diagnostic Device in Patients With Heart Failure
A study testing KV-PREDICT in people with Heart Failure, run by KardioVis S.r.l. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- KV-PREDICT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
S.C. Cardiologia, Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Emilia-Romagna, 41124
Study Principal Investigator, +39 059 4225463, giuseppe.boriani@unimore.it
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- KV-PREDICT
- Keywords
- seismocardiography, cardiac mechanical signals, heart sounds, non-invasive cardiac monitoring, device feasibility, cardiac time intervals, gyrocardiography, cardiac mechanical vibrations
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KV-PREDICTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| KV-PREDICT signal acquisition | Experimental | Single group of adult heart failure patients undergoing one non-invasive KV-PREDICT signal acquisition during a scheduled outpatient visit. Receives: Device: KV-PREDICT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals
Number and corresponding percentage of technically valid and processable acceleration signal acquisitions measured in mG, across patients with different heart-failure severity
Measured: 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
Number and corresponding percentage of technically valid and processable gyroscopic signal acquisitions measured in mDeg/s, across patients with different heart-failure severity
Measured: During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Secondary outcomes (5)
Variability of acquired acceleration signals' amplitude across NYHA classes and left-ventricular function profiles
Variability of amplitude of acceleration signals measured in mG across NYHA classes and left-ventricular function profiles
Measured: 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
Variability of amplitude of gyroscopic signals' amplitude measured in mDeg/s across NYHA classes and left-ventricular function profiles
Measured: 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
Variability of timing of acceleration signals measured in ms across NYHA classes and left-ventricular function profiles
Measured: 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
Variability of timing of gyroscopic signals measured in ms across NYHA classes and left-ventricular function profiles
Measured: 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
Number of adverse events or complaints collected during the recording sessions
Measured: During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KardioVis S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giuseppe Boriani, MD, PhD, Principal investigator, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805213
- Sponsor's protocol ID
- PREDICT-HF
- Other IDs
- 26-06-058156
- Acronym
- PREDICT_HF
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Jafari Tadi M, Lehtonen E, Saraste A, Tuominen J, Koskinen J, Teras M, Airaksinen J, Pankaala M, Koivisto T. Gyrocardiography: A New Non-invasive Monitoring Method for the Assessment of Cardiac Mechanics and the Estimation of Hemodynamic Variables. Sci Rep. 2017 Jul 28;7(1):6823. doi: 10.1038/s41598-017-07248-y.
PubMed 28754888Alhakak AS, Olsen FJ, Skaarup KG, Lassen MCH, Johansen ND, Jorgensen PG, Abildgaard U, Jensen GB, Schnohr P, Sogaard P, Mogelvang R, Biering-Sorensen T. Age- and sex-based normal reference ranges of the cardiac time intervals: the Copenhagen City Heart Study. Clin Res Cardiol. 2025 Apr;114(4):430-442. doi: 10.1007/s00392-023-02269-2. Epub 2023 Jul 31.
PubMed 37522900Shah SJ, Nakamura K, Marcus GM, Gerber IL, McKeown BH, Jordan MV, Huddleston M, Foster E, Michaels AD. Association of the fourth heart sound with increased left ventricular end-diastolic stiffness. J Card Fail. 2008 Jun;14(5):431-6. doi: 10.1016/j.cardfail.2008.01.010. Epub 2008 May 27.
PubMed 18514937Cao M, Gardner RS, Hariharan R, Nair DG, Schulze C, An Q, Thakur PH, Kwan B, Zhang Y, Boehmer JP. Ambulatory Monitoring of Heart Sounds via an Implanted Device Is Superior to Auscultation for Prediction of Heart Failure Events. J Card Fail. 2020 Feb;26(2):151-159. doi: 10.1016/j.cardfail.2019.10.006. Epub 2019 Oct 18.
PubMed 31634574Boriani G, Imberti JF, Bonini N, Carriere C, Mei DA, Zecchin M, Piccinin F, Vitolo M, Sinagra G. Remote multiparametric monitoring and management of heart failure patients through cardiac implantable electronic devices. Eur J Intern Med. 2023 Sep;115:1-9. doi: 10.1016/j.ejim.2023.04.011. Epub 2023 Apr 17.
PubMed 37076404
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Centre, Interventional, Non-Invasive Clinical Study to Evaluate the Performance of the KV-PREDICT Diagnostic Medical Device in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07805213
- Acronym / sponsor ID
- PREDICT_HF / PREDICT-HF
- Conditions
- Heart Failure
- Keywords
- seismocardiography, cardiac mechanical signals, heart sounds, non-invasive cardiac monitoring, device feasibility, cardiac time intervals, gyrocardiography, cardiac mechanical vibrations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KardioVis S.r.l.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KV-PREDICT signal acquisition | Experimental | Device: KV-PREDICTSingle group of adult heart failure patients undergoing one non-invasive KV-PREDICT signal acquisition during a scheduled outpatient visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KV-PREDICTKV-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. | Device | KV-PREDICT signal acquisition |
Primary outcome
Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals
Time frame: 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
Time frame: 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
5 secondary outcomes
Variability of acquired acceleration signals' amplitude across NYHA classes and left-ventricular function profiles
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 28754888Jafari Tadi M, Lehtonen E, Saraste A, Tuominen J, Koskinen J, Teras M, Airaksinen J, Pankaala M, Koivisto T. Gyrocardiography: A New Non-invasive Monitoring Method for the Assessment of Cardiac Mechanics and the Estimation of Hemodynamic Variables. Sci Rep. 2017 Jul 28;7(1):6823. doi: 10.1038/s41598-017-07248-y.
- Background: PubMed 37522900Alhakak AS, Olsen FJ, Skaarup KG, Lassen MCH, Johansen ND, Jorgensen PG, Abildgaard U, Jensen GB, Schnohr P, Sogaard P, Mogelvang R, Biering-Sorensen T. Age- and sex-based normal reference ranges of the cardiac time intervals: the Copenhagen City Heart Study. Clin Res Cardiol. 2025 Apr;114(4):430-442. doi: 10.1007/s00392-023-02269-2. Epub 2023 Jul 31.
- Background: PubMed 18514937Shah SJ, Nakamura K, Marcus GM, Gerber IL, McKeown BH, Jordan MV, Huddleston M, Foster E, Michaels AD. Association of the fourth heart sound with increased left ventricular end-diastolic stiffness. J Card Fail. 2008 Jun;14(5):431-6. doi: 10.1016/j.cardfail.2008.01.010. Epub 2008 May 27.
- Background: PubMed 31634574Cao M, Gardner RS, Hariharan R, Nair DG, Schulze C, An Q, Thakur PH, Kwan B, Zhang Y, Boehmer JP. Ambulatory Monitoring of Heart Sounds via an Implanted Device Is Superior to Auscultation for Prediction of Heart Failure Events. J Card Fail. 2020 Feb;26(2):151-159. doi: 10.1016/j.cardfail.2019.10.006. Epub 2019 Oct 18.
- Background: PubMed 37076404Boriani G, Imberti JF, Bonini N, Carriere C, Mei DA, Zecchin M, Piccinin F, Vitolo M, Sinagra G. Remote multiparametric monitoring and management of heart failure patients through cardiac implantable electronic devices. Eur J Intern Med. 2023 Sep;115:1-9. doi: 10.1016/j.ejim.2023.04.011. Epub 2023 Apr 17.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe Boriani, MD, PhD principal investigator
Azienda Ospedaliero-Universitaria di Modena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KV-PREDICT in people with Heart Failure, run by KardioVis S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Pieraccini, MSc / Eng. (+39 351 5548005, gabriele.pieraccini@kardiovis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals (time frame: During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805213, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.