What side effects are associated with this type of intervention?

Pacemaker adjustments or heart rate manipulation for vasovagal syncope primarily involve altering the pacing modes to limit right ventricular (RV) pacing. Common side effects of these adjustments can include bradycardia, pacemaker syndrome, and potential exacerbation of heart failure symptoms. Additionally, there may be risks of atrial fibrillation, syncope, and inappropriate shocks, although these are generally rare. Overall, the side effects are typically mild to moderate and can be managed with careful monitoring and individualized programming.

What prior FDA approvals exist?

There are no specific FDA-approved drugs solely for the treatment of vasovagal syncope. However, treatments often involve managing underlying conditions and symptoms, such as using beta-blockers, fludrocortisone, or midodrine. For patients with recurrent episodes, especially those resistant to medication, pacemaker implantation has been considered, although it is not universally recommended. The trial involving heart rate manipulation in patients with permanent pacemakers aims to explore non-drug interventions for managing this condition.

What other types of research exist?

Promising novel alternatives to pacemaker adjustment for vasovagal syncope patients in 2024 include advanced neuromodulation techniques such as non-invasive vagus nerve stimulation (nVNS) and innovative pharmacologic agents targeting the autonomic nervous system. Additionally, wearable devices that monitor and predict syncope episodes, allowing for preemptive interventions, are also emerging as potential treatment options.

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Device

Pacing for Fainting (Pacing_SV Trial)

N/A

Recruiting

Led By Satish R Raj, MD MSCI

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-70 years (inclusive)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Pacing_SV Trial Summary

This trial will study how different heart rates affect stroke volume and cardiac output, using pacemaker patients as subjects.

Who is the study for?

This trial is for adults aged 18-70 with a healthy heart pump function (LV ejection fraction >50%) who already have a permanent pacemaker or defibrillator that can control heartbeats. It's not suitable for those who can't consent or need a specific cardiac device.Check my eligibility

What is being tested?

The study aims to understand how different heart rates affect the amount of blood pumped by the heart each beat and overall circulation, using non-invasive methods in patients with devices that can safely adjust their heartbeat.See study design

What are the potential side effects?

Since this trial involves adjusting pacemakers or defibrillators, side effects may include discomfort from changes in heartbeat but no drug-related side effects are expected as it doesn't involve medication.

Pacing_SV Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 70 years old.

Pacing_SV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in cardiac output while atrial pacing at lower and higher rates while supine

Secondary outcome measures

Change in cardiac output at lower and higher ventricular (VVI) paced rates while supine

Change in stroke volume at lower and higher atrial paced rates while tilted up

Change in stroke volume at lower and higher ventricular (VVI) paced rates while tilted up

+4 more

Pacing_SV Trial Design

1Treatment groups

Experimental Treatment

Group I: Stroke volume and cardiac outputExperimental Treatment1 Intervention

Pacing runs will occur at the following rates: 50 beats per minute (bpm) 60 bpm 70 bpm 80 bpm 90 bpm 100 bpm 110 bpm 120 bpm 130 bpm The finger blood pressure cuff will be calibrated between pacing runs. Following the final pacing run while supine, the patient will be given 10 minutes to rest prior to the upright portion of the study. They will then be strapped into the table (so they will not fall) and then they will be tilted up to >70 degrees (almost standing up). They will stand for ~10 minutes prior to commencing the next pacing trains.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pacing

2019

Completed Phase 2

~90

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Vasovagal Syncope, such as pacemaker adjustments, work by stabilizing heart rate and blood pressure to prevent the sudden drops that cause fainting. Pacemakers can be programmed to maintain a minimum heart rate or limit ventricular pacing, ensuring consistent cardiovascular function. This is important for Vasovagal Syncope patients as it helps prevent the episodes of syncope by maintaining stable heart function.

Stop vasodepressor drugs in reflex syncope: a randomised controlled trial.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

796 Previous Clinical Trials

874,764 Total Patients Enrolled

4 Trials studying Vasovagal Syncope

359 Patients Enrolled for Vasovagal Syncope

Satish R Raj, MD MSCIPrincipal InvestigatorUniversity of Calgary

19 Previous Clinical Trials

1,401 Total Patients Enrolled

1 Trials studying Vasovagal Syncope

57 Patients Enrolled for Vasovagal Syncope

Media Library

Permanent Pacemaker (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03446326 — N/A

Vasovagal Syncope Research Study Groups: Stroke volume and cardiac output

Vasovagal Syncope Clinical Trial 2023: Permanent Pacemaker Highlights & Side Effects. Trial Name: NCT03446326 — N/A

Permanent Pacemaker (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03446326 — N/A

~7 spots leftby Jan 2027

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