Data Collection - Of Syncope Tilt Table Testing Study

NCT03721393 | Completed

• 1 other identifier: C2109
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthostatic Hypotension; Reflex Syncope

Keywords

tilt table test, valsalva

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1: Syncope patients

Patients that have undergone an ARS assessment and diagnosed with orthostatic hypotension or reflex syncope.

Device: Wearable heart monitor

Group 2: Control patients

Patients that have undergone an ARS assessment and are control subjects.

Device: Wearable heart monitor

Interventions

Wearable heart monitor DEVICE

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

Group 1: Syncope patients; Group 2: Control patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have previously undergone a ARS assessment and were diagnosed with OH or reflex syncope, or are control subjects.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hypotension, Orthostatic; Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolfgang Singer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 26, 2018
• Study Start: October 4, 2019
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)