Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT05966857
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 22 years;
* Parameters for surgical indication, in the presence of heart disease (mitral or aortic valve disease, coronary artery disease or aortic disease);
* Agree to adhere to the study's procedures and requirements;
* Be able to consent to their participation in writing;
Exclusion Criteria:
* Not having undergone cardiac surgery;
* Presence of post-surgical complications with prolonged hospital stay for more than 14 days from surgery date;
* Presence of a Peripherally Inserted Central Catheter (PICC) or limb preservation and cardiac pacemaker in case of impediment to acquisition of the ECG (smartwatch);
* Patients with arteriovenous fistula;
* Presence of skin pathology or skin diseases such as vitiligo, lupus and atopic dermatitis, as well as tattoos in the wrist region, which may interfere with the reading by the optical sensor;
* Show sensitivity or allergic reactions, to any degree, to the component materials of the wearable device;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05966857
Study Brief:
Protocol Section:
NCT05966857