Recruiting

NCT Number: NCT07464444

An Observational Study of Medical Device, HALD (Heart and Lung Diagnostic) 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:

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.

Recruiting

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Key information

Conditions

Auscultation of Heart and Lungs

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Glen Centre Specilaized Medicine Clinic

Montreal, Quebec, H4A 3T2, Canada

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

<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

Treatment and study plan

Primary outcomes

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.
- 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Liszkowski, MD, Cardiologist

CONTACT

[email protected]

(514) 228-8889

Sponsors and collaborators

Lead sponsor

SonoHL

Industry

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Mar 11, 2026
Registry last updated: Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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