Using wearable devices to predict and detect complications after heart surgery
Official title: The Role of Wearable Devices in Predicting and Detecting Complications and Adverse Events
Run by Massachusetts General Hospital · NCT04824066 · Data updated 2026-11-12
This study is testing if wearable devices can help doctors spot problems early in patients recovering from heart surgery by tracking their activity and sleep.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2400 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | July 10, 2021 |
| Main results expected | January 1, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT04824066 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are undergoing cardiothoracic surgery and can use wearable devices.
✕Probably not a fit
Patients with severe irreversible pulmonary hypertension, congenital heart disease, chronic renal insufficiency, liver cirrhosis, or those who are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research aims to utilize machine learning analysis of data collected from wearable devices to monitor recovery and identify early postoperative complications in patients undergoing cardiothoracic surgery. The study will enroll patients who will wear a device like a Fitbit from approximately 30 days before surgery until 180 days after. The data collected will include activity levels and sleep quality, which will be analyzed to improve patient outcomes. The study is non-randomized and will involve a single center, Massachusetts General Hospital, with a target enrollment of 1,200 subjects.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of complications, improving recovery outcomes for patients after cardiothoracic surgery.
How similar studies have gone: While the use of wearable devices in postoperative monitoring is gaining traction, this specific application in cardiothoracic surgery is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older 2. Individuals scheduled to undergo one of the following surgical or non-surgical treatments: cardiothoracic surgery, orthopedic surgery, vascular surgery, colorectal surgery, pancreatic surgery, other major abdominal surgeries, treatment for chronic disease, or systemic therapy (i.e., chemotherapy, immunotherapy, or targeted therapy), radiotherapy, or ablation. 3. Amenable to using one of the wearable devices of interest (Fitbit, iWatch, Biostrap). 4. Individuals willing to provide informed consent and who have capacity for all study procedures Exclusion Criteria: 1. Individuals with mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with the study protocol. 2. Any pregnant participant.
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Chi-Fu Jeffrey Yang — Massachusetts General Hospital
- Study coordinator: Chi-Fu Jeffrey Yang, MD
- Email: cjyang@mgh.harvard.edu
- Phone: 617-726-5200
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.