Post-Market Surveillance With a Novel mHealth Platform

Atrial Fibrillation Clinical Trial

Official title: Post-Market Surveillance With a Novel mHealth Platform

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Gastrectomy

• NCT number: NCT03436082
• Study type: Observational [Patient Registry]
• Source: Yale University
• Status: Completed
• Start date: January 26, 2018
• Completion date: December 25, 2018