Recruiting

HALD Device

Sponsor:

SonoHL

Code:

NCT07464444

Conditions

Auscultation of Heart and Lungs

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Auscultation of Heart and Lungs

Study ID

NCT07464444

Start date

Jan 7, 2026

Status verified date

Mar, 2026

Completion date

Apr 16, 2027

Anticipated

Primary completion date

Feb 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Evidence of abnormal cardiopulmonary exam and control group without abnormal exam

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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Mark Liszkowski, MD, Cardiologist

(514) 228-8889GCSM@5100SpecMed.com

Locations

Glen Centre Specilaized Medicine Clinic

Recruiting

Montreal, Quebec, Canada, H4A 3T2

More Information

Sponsor

SonoHL

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • HALD - Heart and Lung Diagnostic Vest

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SonoHL on 2026-03-11.