An Observational Study of Medical Device, HALD (Heart and Lung Diagnostic) to Obtain Heart and Lung Sound Recordings.
Recruiting now
Conditions studied: Auscultation of Heart and Lungs
In brief
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.
Key facts
- Study ID
- NCT07464444
- Run by
- SonoHL
- People needed
- 200
- Starts
- 2026-01-07
- Expected to finish
- 2027-04-16
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- <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
Where it is running
- Glen Centre Specilaized Medicine Clinic — Montreal, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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