Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial Prospective

NCT07663799 | Not Yet Recruiting FDA Device

• 1 other identifier: WATCH-XP
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Wearable health technology, particularly smartwatches, has revolutionized personal health monitoring by enabling continuous, non-invasive tracking of various physiological parameters. The potential applications of these devices in cardiology are extensive, but it is crucial to validate their accuracy against established medical-grade devices. The Apple Watch Series 9 (Apple, USA) exemplifies the capabilities of modern smartwatches, offering a wide range of health tracking features. These include heart rate monitoring, detection of irregular heart rhythms suggestive of atrial fibrillation, electrocardiogram recording, blood oxygen level measurement, and comprehensive mobility metrics (including VO2 max, six-minute walk distance, walking speed, step length, double support time, and walking asymmetry). Many of these parameters are highly relevant for cardiovascular patients, potentially aiding in disease progression monitoring and adverse event prediction. However, there is a lack of comprehensive validation studies for these devices in specific cardiovascular disease populations. This investigator-initiated, prospective observational study will consist of two phases: a training phase which involves 50 participants and a prospective validation phase which involves 20 participants. The study aims to validate smartwatch-based assessments using medical-grade devices and techniques. The study will focus on adult patients with congenital heart disease, pulmonary hypertension, heart failure, and coronary artery disease, as well as athletes undergoing cardiovascular assessment. By comparing smartwatch data with established clinical measurements, we seek to determine the reliability and potential clinical utility of these wearable devices in diverse cardiovascular contexts. Anonymized smartwatch data collected during the two phases will be published to a publicly registry to facilitate further research. This research will help bridge the gap between consumer-grade wearable technology and clinical practice in cardiology.

Conditions

Congenital Heart Disease; Pulmonary Hypertension; Heart Failure; Coronary Heart Disease (CHD); Apple Watch

Keywords

apple watch; congenital heart disease; heart failure; coronary heart disease; pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• Correlation between CPX VO2max and smartwatch parameters (virtual VO2 max, physical activity parameters)

  VO2 max (ml/min/kg) concurrently measured with a medical-grade device and a smartwatch which has virutal VO2 max and physical activity parameters as assessed during treadmill exercise

  During treadmill exercise in the day of recruitment and concurrently baseline assessment

Secondary Outcomes (5)

• Correlation between VO2 max (ml/min/kg) obtained using medical-grade device and smartwatch

  During treadmill exercise in the day of recruitment and concurrently baseline assessment

• Correlation between SaO2 (%) obtained using medical-grade device and smartwatch

  During treadmill exercise in the day of recruitment and concurrently baseline assessment

• SaO2 (%) measured by the smartwatch

  During treadmill exercise in the day of recruitment and concurrently baseline assessment

• SaO2 (%) in participants with severe disease and participants with mild disease

  During treadmill exercise in the day of recruitment and concurrently baseline assessment

• Novel markers or patterns

  During treadmill exercise in the day of recruitment and concurrently baseline assessment

Study Arms (1)

WatchXP

Participants will wear the investigational smartwatch (Apple Watch Series 9) concurrently for pre- and post-SaO2 and VO2max assessment during cardiopulmonary exercise test at the visit.

Device: Apple Watch Series 9

Interventions

Apple Watch Series 9 DEVICE

Participant will concurrently be wearing the investigational smartwatch for pre- and post-SaO2 and VO2max assessment.

WatchXP

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having adult congenital heart disease or pulmonary hypertension, heart failure or coronary artery disease, or are athletes undergoing cardiovascular assessment

You may qualify if:

• Age 20 to 70 years old
• Ability to provide informed consent
• History of the following cardiovascular conditions:
• Adult congenital heart disease
• Pulmonary hypertension
• Heart failure
• Coronary artery disease
• Athletes undergoing cardiovascular assessment

You may not qualify if:

• Contraindication for undergoing physical exertion including cardio-pulmonary exercise testing (CPX) and 6-minute walk test (6MWT)
• Pregnancy
• Known allergy to components of the investigational product

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Medicine, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (6)

• Mannhart D, Lischer M, Knecht S, du Fay de Lavallaz J, Strebel I, Serban T, Vogeli D, Schaer B, Osswald S, Mueller C, Kuhne M, Sticherling C, Badertscher P. Clinical Validation of 5 Direct-to-Consumer Wearable Smart Devices to Detect Atrial Fibrillation: BASEL Wearable Study. JACC Clin Electrophysiol. 2023 Feb;9(2):232-242. doi: 10.1016/j.jacep.2022.09.011. Epub 2023 Jan 18.

  PMID: 36858690 RESULT

• Guo Y, Wang H, Zhang H, Liu T, Liang Z, Xia Y, Yan L, Xing Y, Shi H, Li S, Liu Y, Liu F, Feng M, Chen Y, Lip GYH; MAFA II Investigators. Mobile Photoplethysmographic Technology to Detect Atrial Fibrillation. J Am Coll Cardiol. 2019 Nov 12;74(19):2365-2375. doi: 10.1016/j.jacc.2019.08.019. Epub 2019 Sep 2.

  PMID: 31487545 RESULT

• Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

  PMID: 31722151 RESULT

• Chan PH, Wong CK, Poh YC, Pun L, Leung WW, Wong YF, Wong MM, Poh MZ, Chu DW, Siu CW. Diagnostic Performance of a Smartphone-Based Photoplethysmographic Application for Atrial Fibrillation Screening in a Primary Care Setting. J Am Heart Assoc. 2016 Jul 21;5(7):e003428. doi: 10.1161/JAHA.116.003428.

  PMID: 27444506 RESULT

• Wong CK, Lau YM, Lui HW, Chan WF, San WC, Zhou M, Cheng Y, Huang D, Lai WH, Lau YM, Siu CW. Automatic detection of cardiac conditions from photos of electrocardiogram captured by smartphones. Heart. 2024 Aug 14;110(17):1074-1082. doi: 10.1136/heartjnl-2023-323822.

  PMID: 38768982 RESULT

• Wong CK, Un KC, Zhou M, Cheng Y, Lau YM, Shea PC, Lui HW, Zuo ML, Yin LX, Chan EW, Wong ICK, Sin SWC, Yeung PPN, Chen H, Wibowo S, Wei TLN, Lee SM, Chow A, Tong RCF, Hai J, Tam FCC, Siu CW. Daily ambulatory remote monitoring system for drug escalation in chronic heart failure with reduced ejection fraction: pilot phase of DAVID-HF study. Eur Heart J Digit Health. 2022 May 7;3(2):284-295. doi: 10.1093/ehjdh/ztac024. eCollection 2022 Jun.

  PMID: 36713022 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital; Hypertension, Pulmonary; Heart Failure; Coronary Disease

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Myocardial Ischemia

Central Study Contacts

Chun Ka Wong

CONTACT

+852 2255 3111; wongeck@hku.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

HK (1)