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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

Status: Recruiting
Location: See location...
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Glen Centre Specilaized Medicine Clinic
RECRUITING
Montreal
Contact Information
Primary
Mark Liszkowski, MD, Cardiologist
GCSM@5100SpecMed.com
(514) 228-8889
Time Frame
Start Date: 2026-01-07
Estimated Completion Date: 2027-04-16
Participants
Target number of participants: 200
Treatments
Evidence of abnormal cardiopulmonary exam and control group without abnormal exam
Related Therapeutic Areas
Sponsors
Leads: SonoHL

This content was sourced from clinicaltrials.gov