Wearable HALD vest to record heart and lung sounds during clinic visits
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
This project will try a wearable HALD vest that records heart and lung sounds during routine cardiology visits for adults with or without cardiopulmonary conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | SonoHL Industry-sponsored |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT07464444 on ClinicalTrials.gov |
What this trial studies
This is an observational effort to capture heart and lung sounds using the HALD investigational vest immediately after a standard clinic exam and ECG. Participants will wear a T-shirt and the HALD vest while recordings are made in several positions (lying and sitting) and with normal and deep breaths. Recordings will be automatically transferred to a computer, saved securely, and later compared to what the clinician heard during the physical exam. Participants must have had or be scheduled for an echocardiogram within 12 months so recordings can be interpreted in clinical context.
Who should consider this trial
Good fit: Adults (≥18 years) with a history of valvular heart disease, heart failure, pericarditis, coronary artery disease, other abnormal cardiopulmonary findings, or control participants with normal exams who can consent and have an echocardiogram within the prior or upcoming 12 months are ideal candidates.
Not a fit: People under 18, pregnant or lactating women, individuals with implantable electronic devices like pacemakers/ICDs, or those unable to give informed consent are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, the HALD vest could provide reliable, standardized heart and lung sound recordings to support clinical exams and remote monitoring.
How similar studies have performed: Digital and wearable auscultation devices have shown promising results in prior work, but vest-style systems like HALD are relatively novel and still undergoing validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or Female 2. Age ≥18 years old 3. 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. 4. Must have had an echocardiogram performed within 12 months of enrollment or have a scheduled echocardiogram appointment expected within the next 12 months. 5. Able and willing to provide written informed consent for study participation and able to comply with the required testing Exclusion Criteria: 1. \<18 years of age 2. Females pregnant, or lactating mothers 3. Participant with implantable electronic devices such as pacemakers or implantable cardioverter-defibrillator (ICD) 4. Participant has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study evaluation
Where this trial is running
Montreal, Quebec
- Glen Centre Specilaized Medicine Clinic — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Liskowski, MD, Cardiologist — Glen Centre Specilaized Medicine Clinic
- Study coordinator: Mark Liszkowski, MD, Cardiologist
- Email: GCSM@5100SpecMed.com
- Phone: (514) 228-8889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.