Pulmonary Hypertension Drug Efficacy

Untethered six-minute walk test

 

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Study Scope and Protocol

This multi-site, multi-country study involves a six-minute walk test protocol designed to capture ECG rhythm and heart rate before, during and after the routine, while the patient walks a 90 foot designated path.

This study leveraged Vivalink’s Biometric Data Platform and the wearable ECG monitor to analyze patient heart rate changes throughout the routine.

Hypertension

Key Components

  • Biometrics Data Platform
  • Wearable ECG Monitor
  • Custom 6MWT App
  • Retrospective Data Reports
  • Provisioned Kits
  • International Logistics

Data Captured

  • Raw ECG
  • Heart Rate
Requirements/Challenges Solution
Specific clinical protocol required to manage 6MWT routine Customized clinical mobile app to match protocol use case
Logistical challenges with international sites Provisioning and direct ship to international sites
Aggregating data from multi-sites Consolidated data for centralized analysis
Network disconnections during 6MWT routine Auto network recovery and data synchronization
Ensuring data adherence for RPM devices Data acquisition reports to monitor adherence

 

"Medical wearables are making it possible to explore new, potentially meaningful outcomes in clinical studies without adding much additional burden to patients or their clinicians."

-Robert F. Roscigno, PhD, Vice President, Clinical Development at Gossamer Bio