Pacing for Fainting

(Pacing_SV Trial)

Overseen By Satish R Raj, MD MSCI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Cardiac resynchronization device, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

25 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Permanent Pacemaker, Cardiac Pacemaker, Artificial Pacemaker for fainting?

Research shows that dual-chamber pacemakers can significantly reduce the frequency of fainting spells in patients with recurrent neurally mediated syncope, improving their quality of life. In one study, the average number of fainting episodes dropped from 5 per month to 0.3 per month after pacemaker implantation. ^{1 2 3 4 5}

Is a pacemaker generally safe for humans?

Pacemakers are generally safe, but they can sometimes cause issues like dizziness or fainting if not properly adjusted. Some patients may experience symptoms due to pacemaker-related problems or other heart rhythm issues, but these can often be managed with adjustments or medication. ^{1 4 6 7 8}

How is the treatment of fainting with a permanent pacemaker different from other treatments?

A permanent pacemaker is unique because it is an implantable device that helps maintain a steady heart rate by sending electrical signals to the heart when the body's natural pacing system fails. Unlike medications or other treatments, it directly stimulates the heart muscle to prevent fainting caused by irregular heart rhythms. ^{1 9 10 11 12}

What is the purpose of this trial?

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.

Research Team

Satish R Raj, MD MSCI

Principal Investigator

University of Calgary

Eligibility Criteria

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.

Inclusion Criteria

Criterion: Your heart's pumping ability is normal.

You have a permanent pacemaker or defibrillator implanted in your body.

Exclusion Criteria

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

Unable or unwilling to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo pacing runs at various heart rates to assess stroke volume and cardiac output

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Permanent Pacemaker

Trial Overview 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.

Participant Groups

Group I: Stroke volume and cardiac output Experimental Treatment 1 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.

Permanent Pacemaker is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Pacemaker for:

• Bradycardia
• Heart block
• Sick sinus syndrome
• Chronic atrial fibrillation
• Heart failure

Approved in European Union as Pacemaker for:

• Bradycardia
• Heart block
• Sick sinus syndrome
• Chronic atrial fibrillation
• Heart failure

Approved in Canada as Pacemaker for:

• Bradycardia
• Heart block
• Sick sinus syndrome
• Chronic atrial fibrillation
• Heart failure

Approved in Japan as Pacemaker for:

• Bradycardia
• Heart block
• Sick sinus syndrome
• Chronic atrial fibrillation
• Heart failure

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

Patients with cardiac pacemakers who experience syncope should undergo thorough cardiological evaluations, including advanced electrocardiographic tests, to determine if the pacemaker is functioning properly, as modern pacemakers can fail or be improperly programmed.

Proper programming of pacemakers can prevent dangerous arrhythmias and alleviate symptoms like syncope, highlighting the importance of careful regulation and assessment to avoid unnecessary surgeries or complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Syncope and fainting in patients with a cardiac pacemaker]. Dodinot, B., Kubler, L., Medeiros, P.[2009]

In a study of 12 patients with frequent neurally mediated syncope, the use of a dual-chamber pacemaker significantly reduced the frequency of syncopal spells from an average of 5.0 spells per month to just 0.30 spells per month after implantation, indicating its efficacy in preventing fainting episodes.

Patients also reported a substantial improvement in their quality of life, with health perception scores increasing from 55 to 82 on the EuroQol scale and from 51 to 72 on the SF-36 scale, demonstrating the positive impact of the pacemaker on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dual-chamber pacing with automatic rate-drop sensing on recurrent neurally mediated syncope. Sheldon, R., Koshman, ML., Wilson, W., et al.[2022]

Patients experiencing syncope, even when no abnormalities are found, should be considered for pacemaker therapy due to the risks associated with recurrent episodes.

For acute tachyarrhythmias causing hemodynamic collapse, immediate treatment typically involves DC cardioversion, but effective drug therapy and pacemaker use are also crucial for preventing future occurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiarrhythmic therapy in the elderly: pacemakers and drugs. Berman, ND.[2013]

In a study of 1666 patients evaluated for unexplained syncope, 106 received pacemaker (PM) therapy, with indications primarily identified through cardiovascular autonomic testing and ECG monitoring, particularly for sinus arrest and atrioventricular block.

After PM implantation, factors such as treated hypertension, reduced kidney function, and atrial fibrillation were linked to higher rates of recurrent syncope and fall-related injuries, with recurrent syncope significantly predicting increased mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pacing therapy in the management of unexplained syncope: a tertiary care centre prospective study. Yasa, E., Ricci, F., Holm, H., et al.[2021]

In a study of 236 patients with unexplained syncope, those who received a permanent pacemaker (135 patients) experienced significantly fewer syncope episodes (4.4%) compared to those who did not receive a pacemaker (24.8%) over an average follow-up of 4 years.

The findings suggest that identifying patients with atrioventricular (AV) node disease through electrophysiology studies can help determine who would benefit from permanent pacing, potentially reducing the incidence of recurrent syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Permanent pacemaker implantation in unexplained syncope patients with electrophysiology study-proven atrioventricular node disease. Doundoulakis, I., Gatzoulis, KA., Arsenos, P., et al.[2022]

In a study of 570 patients with permanent pacemakers, 8.6% experienced persistent symptoms like palpitations, dizziness, or syncope, with symptoms being more common but less severe in those with dual-chamber pacemakers compared to ventricular pacemakers.

Treatment of symptoms related to pacemaker issues or tachyarrhythmias led to significant improvement in 28 out of 29 patients, highlighting the importance of identifying the underlying cause for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persisting symptoms despite permanent pacing. Incidence, causes, and follow-up. Hoffman, A., Jost, M., Pfisterer, M., et al.[2019]

A case study of a 57-year-old woman with a dual-chamber pacemaker revealed that inappropriate pacing inhibition, caused by the device's internal functions, led to symptoms like lightheadedness due to intermittent ventricular pacing inhibition.

Adjusting the ventricular lead sensitivity from 0.9 mV to 1.2 mV successfully resolved the issue, highlighting the importance of monitoring and adjusting pacemaker settings to prevent complications from device algorithms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case report of inappropriate inhibition of ventricular pacing due to a unique pacemaker electrogram storage feature. Khan, HR., Chan, WK., Kanawati, J., et al.[2022]

A 68-year-old male experienced tachycardia associated with a Medtronic pacemaker, which was triggered by premature ventricular beats, highlighting a potential complication of pacemaker therapy.

Replacing the original pacemaker with a different model successfully resolved the tachyarrhythmia, indicating that device selection is crucial for patient safety and effective management of heart rhythm disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pacer-induced tachycardia associated with an atrial synchronous ventricular inhibited (ASVIP) pulse generator. Tolentino, AO., Javier, RP., Byrd, C., et al.[2019]

Permanent cardiac pacemakers are crucial for patients whose natural heart rate regulation fails, as they provide electrical stimulation to maintain a normal heart rate.

The article discusses the indications for needing a pacemaker, the technical aspects of the procedure, and the necessary care for patients undergoing this implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of permanent cardiac pacing. Jackson, A.[2011]

A pacemaker is a crucial medical device that helps regulate heartbeats by generating electrical signals when the heart's natural rhythm fails, and it can be used temporarily or permanently.

The first permanent pacemaker was successfully implanted in 1958, marking a significant advancement in cardiac care for patients with irregular heart rhythms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pacemakers. Thomas, S.[2019]

In a study of 115 patients with syncope and bifascicular block, those who received pacemakers experienced significantly fewer major study-related events compared to those monitored with an implantable loop recorder (ILR), regardless of the type of bundle branch block (BBB).

The study found that neither the type of BBB nor the presence of PR interval prolongation predicted adverse events in patients monitored with ILR, suggesting that pacemaker implantation is a more effective intervention for reducing risks in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of bundle branch block morphology on outcomes of patients with syncope and bifascicular block: A SPRITELY (POST 3) substudy. Neira, V., Enriquez, A., Sheldon, R., et al.[2023]

In a study of 131 patients undergoing emergency permanent pacemaker implantation, the use of a temporary transvenous pacing lead (TTPL) was identified as a significant predictor of one-year mortality, with a hazard ratio of 2.82, indicating a higher risk of death associated with its use.

Patients with a history of myocardial infarction (MI) and stroke were found to have a higher likelihood of experiencing in-hospital adverse events, with odds ratios of 5.01 and 3.51, respectively, highlighting the importance of these comorbidities in patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parameters associated with one-year mortality and in-hospital adverse events in patients after emergency pacemaker implantation. Mańkowska-Załuska, B., Chudzik, M., Łobodziński, S., et al.[2017]

References

1. France pubmed.ncbi.nlm.nih.gov

[Syncope and fainting in patients with a cardiac pacemaker]. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of dual-chamber pacing with automatic rate-drop sensing on recurrent neurally mediated syncope. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Antiarrhythmic therapy in the elderly: pacemakers and drugs. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Pacing therapy in the management of unexplained syncope: a tertiary care centre prospective study. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Permanent pacemaker implantation in unexplained syncope patients with electrophysiology study-proven atrioventricular node disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Persisting symptoms despite permanent pacing. Incidence, causes, and follow-up. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A case report of inappropriate inhibition of ventricular pacing due to a unique pacemaker electrogram storage feature. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Pacer-induced tachycardia associated with an atrial synchronous ventricular inhibited (ASVIP) pulse generator. [2019]

9. England pubmed.ncbi.nlm.nih.gov

An overview of permanent cardiac pacing. [2011]

10. England pubmed.ncbi.nlm.nih.gov

Pacemakers. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Impact of bundle branch block morphology on outcomes of patients with syncope and bifascicular block: A SPRITELY (POST 3) substudy. [2023]

12. Poland pubmed.ncbi.nlm.nih.gov

Parameters associated with one-year mortality and in-hospital adverse events in patients after emergency pacemaker implantation. [2017]