NCT03721393

Data Collection - Of Syncope Tilt Table Testing Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device. To evaluate the relationship of signals measured from the wearable cardiac monitor prototype device with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.

Detailed description

This is a non-randomized feasibility study that will enroll up to 50 participants that have undergone a previous autonomic reflect screen (ARS) assessment and were either diagnosed with OH or reflex syncope, or considered to be control subjects for this study. A maximum of 20 subjects diagnosed with reflex syncope, a maximum of 10 subjects diagnosed with OH and a maximum of 10 control subjects will be enrolled. There will be one study visit per subject.

Conditions

• Orthostatic Hypotension
• Reflex Syncope

Interventions

Type	Name	Description
DEVICE	Wearable heart monitor	Participants will be fitted with a wearable heart monitor placed on the skin that measures physiologic signals. There is no intervention or treatment.

Timeline

• Start date: 2019-10-04
• Primary completion: 2023-05-08
• Completion: 2023-05-08
• First posted: 2018-10-26
• Last updated: 2023-08-02

Locations

1 site across 1 country: United States