Auscultation of Heart and LungsNCT07464444
An Observational Study of Medical Device, HALD (Heart and Lung Diagnostic) to Obtain Heart and Lung Sound Recordings.
An observational study of Auscultation of Heart and Lungs, run by SonoHL at 1 site in Canada.
Trial summary
The goal of this observational study is to learn whether the HALD investigational device can accurately record heart, and lung sounds during a routine cardiology clinic visit. The main question aims to answer: Can the HALD device capture heart and lung sounds in different positions and during deep breaths, and do… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Auscultation of Heart and Lungs
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jan 2026to 16 Apr 2027
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants presenting to pre-scheduled cardiology appointment, with suspected or history of known; valvular disease, heart failure, pericarditis, coronary artery disease, and other cardiovascular disease.
Who may be able to join
- Male or Female
- Age ≥18 years old
- Documented history of valvular heart disease, heart failure, pericarditis, coronary artery disease or other conditions with abnormal clinical cardiopulmonary assessment as well as control participants without abnormal physical examinations for a total of 60 participants.
- Must have had an echocardiogram performed within 12 months of enrollment or have a scheduled echocardiogram appointment expected within the next 12 months.
- Able and willing to provide written informed consent for study participation and able to comply with the required testing
Who cannot join
- <18 years of age
- Females pregnant, or lactating mothers
- Participant with implantable electronic devices such as pacemakers or implantable cardioverter-defibrillator (ICD)
- Participant has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study evaluation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Glen Centre Specilaized Medicine Clinic
Montreal, Quebec, H4A 3T2
About this study
Official title: An Observational Prospective Study to Assess the Feasibility of a Cardiorespiratory Medical Device, HALD (Heart and Lung Diagnostic) and Its Ability to Obtain Heart and Lung Sound Recordings
The goal of this observational study is to learn whether the HALD investigational device can accurately record heart, and lung sounds during a routine cardiology clinic visit.
The main question aims to answer:
Read more
Can the HALD device capture heart and lung sounds in different positions and during deep breaths, and do these recordings match the sounds assessed by the investigator during a physical exam?
Participants will have a clinical assessment performed by the investigator as per clinic standard of care. After which, the HALD device vest will be applied to the chest of the participant , and heart and lung sounds will be recorded in a series of positions. The recordings will be transferred automatically to a computer and will later be listened to and assessed for accuracy.
The information collected will be used for research purposes to help understand how the device vest may be used in the future.
Read the detailed description
This study is looking at how well the HALD device can record heart and lung sounds during a routine cardiology clinic visit. All participants will have a required clinic exam and ECG performed. Participants who qualify and agree to participate will put on a T-shirt and wear the HALD vest while heart and lung sounds are recorded in several positions, including lying down and sitting, with normal and deep breaths. The recorded sounds will later be compared to what the investigator heard during the exam to check for validity and accuracy. All recordings are saved securely and will be used to help researchers understand how the device could support heart and lung assessments in the future.
- Conditions
- Auscultation of Heart and Lungs
- Keywords
- HALD - Heart and Lung Diagnostic Vest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Evidence of abnormal cardiopulmonary exam and control group without abnormal exam | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The secondary objection is validity and accuracy Between HALD Vest Audio Recordings and Clinical Auscultation Findings
The number of participants recorded heart and lung sounds from the HALD vest that match the clinical cardiologist auscultation findings as evaluated by a blinded cardiologists interpretations
Measured: From initiation of the first vest recording position to the end of the 4-minute recording period.
Feasibility of HALD Vest Use: Outcome Measure: Feasibility of applying the HALD vest in a clinical setting, including ease of donning, participant comfort, workflow integration, and successful acquisition of heart and lung audio recordings.
- Percentage of participants who rated putting on the vest (with CRC assistance) as easy on a 5-point Likert scale (0 = very easy to 4 = very difficult).
Measured: From the time of the applying the vest to the participant to the end of the 4-minute recording period.
To assess participant overall physical comfort while wearing the vest in the varying recording positions.
Percentage of participants rating comfort while wearing the vest on a 5-point Likert scale (1 = very comfortable to 5 = very uncomfortable).
Measured: From initiation of the first vest recording position to the end of the 4-minute recording period.
Measure the degree of difficulty for the research team to perform tasks required of the HALD vest device ( fitting the vest on the participant, positioning for recordings, obtaining recordings and data entry in computer )
Percentage of CRCs rating the overall HALD vest workflow (fitting the vest, positioning the participant, obtaining recordings, and entering data into the SonoHL system) on a 5-point Likert scale from very easy to very difficult.
Measured: From the time of the applying the vest to the participant to the end of the 4-minute recording period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start7 Jan 2026
- Primary completion12 Feb 2027 (estimated)
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auscultation of Heart and LungsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SonoHL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liskowski, MD, Cardiologist, Principal investigator, Glen Centre Specilaized Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464444
- Sponsor's protocol ID
- HALD-002
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan as of yet, to be defined
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Prospective Study to Assess the Feasibility of a Cardiorespiratory Medical Device, HALD (Heart and Lung Diagnostic) and Its Ability to Obtain Heart and Lung Sound Recordings
- ClinicalTrials.gov ID
- NCT07464444
- Acronym / sponsor ID
- HALD-002
- Conditions
- Auscultation of Heart and Lungs
- Keywords
- HALD - Heart and Lung Diagnostic Vest
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- SonoHLIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 12 Feb 2027 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 11 Mar 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.
The goal of this observational study is to learn whether the HALD investigational device can accurately record heart, and lung sounds during a routine cardiology clinic visit.
The main question aims to answer:
Can the HALD device capture heart and lung sounds in different positions and during deep breaths, and do these recordings match the sounds assessed by the investigator during a physical exam?
Participants will have a clinical assessment performed by the investigator as per clinic standard of care. After which, the HALD device vest will be applied to the chest of the participant , and heart and lung sounds will be recorded in a series of positions. The recordings will be transferred automatically to a computer and will later be listened to and assessed for accuracy.
The information collected will be used for research purposes to help understand how the device vest may be used in the future.
Detailed description
This study is looking at how well the HALD device can record heart and lung sounds during a routine cardiology clinic visit. All participants will have a required clinic exam and ECG performed. Participants who qualify and agree to participate will put on a T-shirt and wear the HALD vest while heart and lung sounds are recorded in several positions, including lying down and sitting, with normal and deep breaths. The recorded sounds will later be compared to what the investigator heard during the exam to check for validity and accuracy. All recordings are saved securely and will be used to help researchers understand how the device could support heart and lung assessments in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evidence of abnormal cardiopulmonary exam and control group without abnormal exam | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants presenting to pre-scheduled cardiology appointment, with suspected or history of known; valvular disease, heart failure, pericarditis, coronary artery disease, and other cardiovascular disease.
Key inclusion criteria (5 listed)
- Male or Female
- Age ≥18 years old
- Documented history of valvular heart disease, heart failure, pericarditis, coronary artery disease or other conditions with abnormal clinical cardiopulmonary assessment as well as control participants without abnormal physical examinations for a total of 60 participants.
- Must have had an echocardiogram performed within 12 months of enrollment or have a scheduled echocardiogram appointment expected within the next 12 months.
- Able and willing to provide written informed consent for study participation and able to comply with the required testing
Key exclusion criteria (4 listed)
- <18 years of age
- Females pregnant, or lactating mothers
- Participant with implantable electronic devices such as pacemakers or implantable cardioverter-defibrillator (ICD)
- Participant has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The secondary objection is validity and accuracy Between HALD Vest Audio Recordings and Clinical Auscultation Findings
Time frame: From initiation of the first vest recording position to the end of the 4-minute recording period.
The number of participants recorded heart and lung sounds from the HALD vest that match the clinical cardiologist auscultation findings as evaluated by a blinded cardiologists interpretations
Feasibility of HALD Vest Use: Outcome Measure: Feasibility of applying the HALD vest in a clinical setting, including ease of donning, participant comfort, workflow integration, and successful acquisition of heart and lung audio recordings.
Time frame: From the time of the applying the vest to the participant to the end of the 4-minute recording period.
1. Percentage of participants who rated putting on the vest (with CRC assistance) as easy on a 5-point Likert scale (0 = very easy to 4 = very difficult).
To assess participant overall physical comfort while wearing the vest in the varying recording positions.
Time frame: From initiation of the first vest recording position to the end of the 4-minute recording period.
Percentage of participants rating comfort while wearing the vest on a 5-point Likert scale (1 = very comfortable to 5 = very uncomfortable).
Measure the degree of difficulty for the research team to perform tasks required of the HALD vest device ( fitting the vest on the participant, positioning for recordings, obtaining recordings and data entry in computer )
Time frame: From the time of the applying the vest to the participant to the end of the 4-minute recording period.
Percentage of CRCs rating the overall HALD vest workflow (fitting the vest, positioning the participant, obtaining recordings, and entering data into the SonoHL system) on a 5-point Likert scale from very easy to very difficult.
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 11 Mar 2026.
- Individual participant dataSharing planned: No. No plan as of yet, to be defined
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.
Liskowski, MD, Cardiologist principal investigator
Glen Centre Specilaized Medicine Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auscultation of Heart and Lungs, run by SonoHL at 1 site in Canada.
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: looking for participants now, as of the sponsor's last update on 11 Mar 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 Canada. 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 Mark Liszkowski, MD, Cardiologist ((514) 228-8889, GCSM@5100SpecMed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The secondary objection is validity and accuracy Between HALD Vest Audio Recordings and Clinical Auscultation Findings (time frame: From initiation of the first vest recording position to the end of the 4-minute recording period.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.