Data Collection - Of Syncope Tilt Table Testing Study

Completed

• Conditions: Orthostatic Hypotension; Reflex Syncope
• Interventions: Device: Wearable heart monitor

• Registration Number: NCT03721393
• Lead Sponsor: Boston Scientific Corporation

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.

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.

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Study Start: 2019-10-04
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Last Update Submitted: 2023-07-31
• Status Verified: 2023-08
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2: Control patients	Wearable heart monitor	Patients that have undergone an ARS assessment and are control subjects.
Group 1: Syncope patients	Wearable heart monitor	Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope.

Primary Outcome Measures

Name	Time	Method
Physiologic Signal Detection	12 months	Characterize the impact of orthostatic hypotension (OH) and reflex syncope on physiologic signals measured using a wearable cardiac monitor prototype device.

Trial Locations

Locations (1)

Mayo Clinic Foundation; 🇺🇸 Rochester, Minnesota, United States