Data Collection - Of Syncope Tilt Table Testing Study

NCT ID: NCT03721393

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2023-05-08

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.

Conditions

Orthostatic Hypotension; Reflex Syncope

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1: Syncope patients

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

Wearable heart monitor

Intervention Type: 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 2: Control patients

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

Wearable heart monitor

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Singer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Foundation

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

C2109

Identifier Type: -

Identifier Source: org_study_id