Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT03721393
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2018-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Data Collection - Of Syncope Tilt Table Testing Study
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Data Collection - Of Syncope Tilt Table Testing Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COST3
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: