Post-Market Surveillance With a Novel mHealth Platform

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