NCT03647085

Data Collection Atrial Fibrillation Exploratory Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable cardiac monitor prototype device. To evaluate the relationship of AFib/AFl symptom severity with various physiologic signals measured from the wearable cardiac monitor prototype device.

Detailed description

The is a non-randomized feasibility study that will enroll up to 50 participants with an ongoing episode of AFib/AFl and are referred for a cardiac ablation or electrical cardioversion procedure. A maximum of 20 persistent AFib, 20 paroxysmal AFib, and 20 AFl participants will be enrolled, not to exceed 50 total. There will be up to three data collection visits. Visit 1 will occur on the same day as enrollment and prior to the cardiac ablation or electrical cardioversion procedure. This allows collection of physiologic signals while the patient is in AFib or AFI. Visit 2 will occur after the cardiac ablation or electrical cardioversion procedure; no earlier than the day after the cardiac ablation or electrical cardioversion procedure and no more than 4 months after the day of the procedure. Visit 3 is optional, and may be scheduled upon sponsor's request, which will take place at least 5 months after the previous (second) data collection visit.

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
DEVICE	Wearable cardiac monitor	Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.

Timeline

• Start date: 2018-08-29
• Primary completion: 2019-01-10
• Completion: 2019-01-10
• First posted: 2018-08-27
• Last updated: 2022-06-09

Locations

1 site across 1 country: United States