Data Collection - Of Syncope Tilt Table Testing Study

Orthostatic Hypotension Clinical Trial

— COST3  

Official title:

Data Collection - Of Syncope Tilt Table Testing Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721393
• Other study ID #: C2109
• Status: Completed
• Start date: October 4, 2019
• Est. completion date: May 8, 2023

Study information

• Verified date: August 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Currently enrolled in another clinical trial that might interfere with data collection.
• Subject is pregnant or planning to become pregnant during the study
• Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.
• Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.
• Known allergy to materials used in the study (adhesive, ECG electrodes)
• Diagnosed with syncope due to cardiologic causes.
• Have had a myocardial infarction in the previous 90 days
• Have been diagnosed with tachycardia that requires medical treatment
• Experienced complications during previous clinically indicated ARS assessment
• Are on medications that could affect autonomic function, if considered not safe or unwilling to hold such medications for at least four half-lives prior to testing (judged by the study Principal Investigator)
• Have any contraindication for tilt test, Valsalva maneuver test or deep breathing test

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Reflex Syncope
• Syncope

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic Foundation	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiologic Signal Detection	Characterize the impact of orthostatic hypotension (OH) and reflex syncope on physiologic signals measured using a wearable cardiac monitor prototype device.	12 months