Data Collection - Of Syncope Tilt Table Testing Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Willing and capable to provide informed consent

• Age 18 or above

• No contraindications to undergo tilt table test, Valsalva maneuver test, and deep breathing test (Components of the ARS assessment)

• Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing). Previously diagnosed with OH, reflex syncope, OR control subjects assessed as normal, based on the ARS assessment. Patient enrollment shall be based on the type of diagnosis.

• Willing to participate in one additional tilt table test, Valsalva maneuver test, and deep breathing test (components of the ARS assessment)

Locations
United States
Minnesota
Mayo Clinic Foundation
Recruiting
Rochester
Contact Information
Primary
Ashley M Jensen, MS
ashley.jensen@bsci.com
651.582.4908
Backup
Stephen Ruble, PhD
stephen.ruble@bsci.com
651.582.4397
Time Frame
Start Date: October 4, 2019
Estimated Completion Date: July 2023
Participants
Target number of participants: 50
Treatments
Group 1: Syncope patients
Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope.
Group 2: Control patients
Patients that have undergone an ARS assessment and are control subjects.
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

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