NCT04971993

Step and Walking Pattern From Cardiac Monitor Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To understand the feasibility of characterizing walking patterns in heart failure subjects and subjects at risk for arrhythmias using an investigational wearable monitor called the SWAN study system.

Detailed description

This is a non-randomized, feasibility study that will enroll up to 60 participants diagnosed with Class II (30-35%) or III (30-35%) heart failure or are indicated for an insertable cardiac monitor with no history of heart failure (30-35%). There will be one study visit per participant and a follow up phone call. The study visit includes device placement and data collection during rest and during a 6 minute hall walk. The device will then be removed.

Conditions

• Heart Failure NYHA Class II
• Heart Failure NYHA Class III
• Insertable Cardiac Monitor

Interventions

Type	Name	Description
DEVICE	Wearable Cardiac Monitor	Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.

Timeline

• Start date: 2022-01-05
• Primary completion: 2023-10-11
• Completion: 2023-10-11
• First posted: 2021-07-22
• Last updated: 2023-12-13

Locations

1 site across 1 country: United States