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

Must not have

Clinical need for a cardiac resynchronization device

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

Summary

This trial will change the heart rates of patients with pacemakers to see how it affects the amount of blood their hearts pump. Researchers want to understand if faster heartbeats give the heart less time to fill with blood, which might affect its efficiency.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need a device to help my heart beat in sync.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 2Eligibility 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.