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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different heart rates affect blood flow and heart function in individuals with permanent pacemakers (also known as cardiac or artificial pacemakers). Researchers will adjust pacemaker settings to observe how changes in heart rate impact stroke volume (the amount of blood the heart pumps with each beat) and cardiac output (the total blood flow from the heart). This study targets individuals with a permanent pacemaker who can tolerate heart rate changes, particularly those with a heart efficiency measure above 50%. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance pacemaker settings for improved heart health.

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 prior data suggests that this protocol is safe for patients with permanent pacemakers?

Research has shown that permanent pacemakers are generally safe for patients. In one study, serious complications such as a collapsed lung occurred in only about 4% of cases. Another issue, where the pacemaker's wire moved out of place, affected around 8% of patients.

Most side effects are manageable and not life-threatening. Common minor issues include mild vein inflammation in about 13% of patients. While complications can occur, they are not very common.

Overall, pacemakers have a strong safety record. They effectively control heart rates, which is crucial for people with certain heart conditions. This reliability makes them a trusted choice for many patients and doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pacing for Fainting trial because it explores a unique approach to managing fainting spells using a permanent pacemaker. Unlike traditional treatments that might focus on lifestyle changes or medications to manage symptoms, this trial investigates how adjusting the heart rate using a pacemaker can directly influence stroke volume and cardiac output. By testing different pacing rates, the trial aims to fine-tune heart function to prevent fainting episodes more effectively. This could lead to a more precise and tailored treatment option for individuals who experience fainting, potentially offering a new avenue for those who don't respond well to current therapies.

What evidence suggests that a permanent pacemaker is effective for managing fainting?

Research has shown that permanent pacemakers, studied in this trial, can effectively reduce fainting, particularly for those who frequently faint due to heart issues. One study found that the recurrence of fainting dropped to just 4.3% over about a year. Other research suggests that pacemakers can reduce fainting by 80%. These devices maintain a steady heartbeat, improving blood flow and reducing symptoms. Overall, pacemakers offer a promising option for managing fainting caused by heart rhythm problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Satish R Raj, MD MSCI

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7896452/

Permanent pacemaker implantation in unexplained ... Over a mean follow‐up of approximately 4 years (50.39 ± 32.40 months), the primary outcome event (syncope) occurred in 18 of 122 patients (14.8%), 6 of 80 (7.5 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666668523000526

Outcomes of permanent pacemakers and implantable ... For PPM patients, 41% had a pacing percentage below 33%, 13% had 33–66%, and 46% had above 66%. One fifth required PPM upgrade, most to cardiac ...

3. ahajournals.org ahajournals.org/doi/10.1161/hc2601.091708

Permanent Cardiac Pacing Versus Medical Treatment for ... The interim analysis showed a significant effect in favor of permanent cardiac pacing (recurrence of syncope in 2 patients [4.3%] after a median of 390 days) ...

4. academic.oup.com academic.oup.com/eurheartj/article/25/19/1741/528715

randomized, double-blind, placebo-controlled study of ... Furthermore, we anticipated a further 80% reduction in syncope recurrence produced by the therapeutic effect of pacemaker treatment.11,12 Based on these data, ...

5. jacc.org jacc.org/doi/10.1016/S0735-1097%2898%2900549-X

The North American vasovagal pacemaker study (VPS) §2 The study goal was to evaluate the effect of permanent pacemaker implantation on syncope in patients with frequently recurrent vasovagal syncope.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6352172/

Safety of Permanent Pacemaker Implantation: A Prospective ... The most frequent major complications were pneumothorax (3.87%) and lead dislodgement (8.39%), while superficial phlebitis (12.90%) and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11366987/

Navigating Complications in Cardiac Pacemakers This review meticulously analyzes these complications, elucidating their mechanisms, clinical implications, and the economic consequences associated with their ...

8. jacc.org jacc.org/doi/10.1016/j.jacep.2021.10.003

Randomized Pragmatic Trial of Pacemaker Versus ... Empiric permanent pacing compared with ICM reduced major adverse events but not syncope in older patients with bifascicular block and recent syncope.

9. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.110.976076

Complication Rates Associated With Pacemaker or ... Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to ...

10. ahajournals.org ahajournals.org/doi/10.1161/circep.112.975102

Prevention of Syncope Through Permanent Cardiac ... The objective of the study was to demonstrate that permanent dual chamber (DDD) pacing is effective in reducing the recurrence of symptoms, ...