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New treatment option for Heart Diseases
Official title FAPO-2: Cardiac Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection
ClinicalTrials.gov ID: NCT07174206
What this study is testing
- What it's testing
- The FAPO-2 study (Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection) is a prospective, interventional, non-randomized study designed to evaluate the feasibility, usability, clinical effectiveness, and cost-efficiency of a wearable-enabled remote monitoring strategy in adult cardiac patients. The intervention consists of active clinical management of patients via teleconsultations, triggered by automated alerts generated through wearable data integrated into a centralized digital platform.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Patients diagnosed with cardiovascular disease, of both sexes, aged over 22 years;
- Provision of informed consent through signature of the Informed Consent Form (ICF);
- Assentation to adhere to study procedures and requirements;
- Patients indicated for outpatient follow-up due to a cardiovascular condition, or with clinical parameters indicating the need for conventional...
- Low or no risk of skin injury, based on Braden Scale clinical criteria or clinical team assessment
You likely can't join if
- Presence of skin conditions, such as vitiligo, lupus, or atopic dermatitis, as well as tattoos on the wrist that may interfere with the smartwatch's...
- Known sensitivity or history of allergic reactions to components of the wearable devices or related items, such as adhesives or electrodes;
- Inability to properly use the wearable monitoring devices due to physical, cognitive, or technological limitations;
- Presence of a peripherally inserted central catheter (PICC) or arteriovenous fistula;
- Presence of implanted cardiac devices, such as pacemakers, defibrillators, or cardiac resynchronization devices, which prevent ECG acquisition via...
- Diagnosis of conditions associated with narrowing or obstruction of the aorta and subclavian arteries (e.g., Stanford Type A chronic aortic...
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.