NCT02542163

Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: NimbleHeart Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purpose: To conduct a pilot study to assess the feasibility of the NimbleHeart wireless telemetry vest in cardiac rehabilitation. Study Design: This is a prospective, single center, non-randomized, pilot trial evaluating the NimbleHeart chest harness system.

Detailed description

20 subjects will be consented to participate at an early cardiac rehabilitation exercise session (typically sessions 1-6). Subjects will wear the NimbleHeart vest concurrently with existing telemetry system during exercise sessions, and thus not replace existing telemetry monitoring. Both staff and subjects will be queried for their (user) experiences during and after each session. Experiences will be documented on surveys after each session. De-identified ECG rhythm strips from the NimbleHeart monitor will be collected to assess quality of tracings. Subjects will be asked to wear the NimbleHeart vest for 2 sessions. Study participation will end after the 2nd session.

Conditions

• Cardiac Rehabilitation

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-09-04
• Last updated: 2016-04-04

Locations

1 site across 1 country: United States