Tilt Table vs Recorder Study for Fainting

(STUTTER Trial)

Recruiting at 1 trial location

Overseen By Roopinder Sandhu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Informed consent, Follow up, Carotid sinus

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for people aged 50 or older who have fainted in the last year and still don't know why, even after a physical exam and heart rhythm test. They shouldn't be at high risk of dying from the fainting, able to agree to participate, and can come back for check-ups.

Inclusion Criteria

You are not at risk of dying from fainting.

I have had fainting episodes in the last year.

My diagnosis is still uncertain after basic tests.

Exclusion Criteria

I am unable to understand and give consent for treatment.

I cannot go to regular check-ups at the clinic.

You have had a positive carotid sinus massage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either early Head-Up Tilt Table procedure or early Implantable Loop Recorder

1 week

1 visit (in-person) for ILR implantation or HUT procedure

Follow-up

Participants are monitored for diagnosis and safety, with follow-up visits every 6 months

3 years

Biannual visits (in-person) and additional visits after symptomatic events

Treatment Details

Interventions

• Head Up Tilt Table (HUT)
• Implantable Loop Recorder

Trial Overview The study is comparing two standard ways to figure out why someone faints: using a tilt table that changes their position or putting in a tiny device under the skin that records heart activity over time.

Participant Groups

Group I: All eligible participants Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+