Syncope Trial to Understand Tilt Testing Early or Recorders Study

NCT03974412 | Completed FDA Device

• 1 other identifier: Pro00087832
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Pragmatic research study to determine which of the two standard syncope therapies yields a faster path to diagnosis- head up tilt (HUT) table or implantable loop recorder (ILR).

Conditions

Syncope

Keywords

syncope; head-up tilt table; implantable loop recorder; pragmatic

Outcome Measures

Primary Outcomes (1)

• Time to diagnosis

  the proportion of patients with a definite diagnosis by 1 year.

  1 year

Study Arms (1)

All eligible participants

EXPERIMENTAL

All eligible participants are randomly assigned to one of two interventions- early Head-Up Tilt Table procedure or early Implantable Loop Recorder. The assignment is random and at a 1:1 ratio between the two strategies.

Diagnostic Test: Head Up Tilt Table (HUT); Device: Implantable Loop Recorder

Interventions

Head Up Tilt Table (HUT) DIAGNOSTIC_TEST

Participant randomized to open-label diagnostic strategy. Results and all follow-up care to be in the hands of treating cardiologist as this is a pragmatic study. the early HUT \[protocol: supine pre-tilt phase 5 min, un-medicated HUT to 70 degrees for 20 minutes; if response negative then 400 μg of sublingual nitroglycerin and continued 70 degree tilt for 20 minutes\]

All eligible participants

Implantable Loop Recorder DEVICE

ILR is a small subcutaneously implanted device, lasting up to 3 years, that records heart rhythms, and which may be either auto-triggered or patientactivated.

All eligible participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• syncope (defined in 2017 ACC/AHA/HRS guidelines\[16\]) in the prior 12 months
• diagnosis unclear after history, physical exam andelectrocardiogram
• no apparent risk of death due to the cause of syncope.

You may not qualify if:

• inability to give informed consent
• unable to attend routine follow up in device clinic
• positive carotid sinus massage.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 4, 2019
• Study Start: May 28, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)