Post-Market Surveillance With a Novel mHealth Platform
Post-Market Surveillance With a Novel mHealth Platform
This is a study to pilot the feasibility of using a novel patient-led, smartphone-based
 mobile health platform (Hugo) for real-world surveillance of outcomes of patients after they
 undergo a bariatric surgical procedure (either sleeve gastrectomy or gastric bypass) and
 catheter-based atrial fibrillation ablation
The plan is to pilot test a novel patient-led, smartphone-based mobile health platform
 (called Hugo) for real-world surveillance of outcomes in 60 total patients after medical
 device use. Research associates will be recruiting patients before they undergo a bariatric
 surgical procedure (either sleeve gastrectomy or gastric bypass) and catheter-based atrial
 fibrillation ablation. Patients will then be queried about specific symptoms related to their
 procedure. Patients will also be given syncable devices to use that will provide additional
 insights into their health and health outcomes. This pilot project will engage patients to
 report outcomes while also synchronizing data from their electronic health records and
 pharmacy accounts to ascertain the ability of emerging mobile health technologies to aid in
 post-marketing surveillance.
Inclusion Criteria:

 -  Age >18

 -  English-speaking

 -  Planned for either a bariatric surgical procedure (either sleeve gastrectomy or
 gastric bypass) or catheter-based atrial fibrillation ablation

 -  Participant is willing and able to read and sign consent and participate in study

 -  Participant has an email account and a mobile device (smartphone or tablet) able to
 download the necessary applications

 -  Participant is willing to use the mobile health platform and syncable devices (e.g.
 Fitbit Charge 2)

 -  Attending bariatric surgeon or electrophysiologist (as appropriate) concurs that
 patient is a candidate for enrollment

 Exclusion Criteria:

 Healthy patients

 Patients who refuse participation