Heart Rate Control for Cerebrovascular Physiology

Overseen By Satish R Raj, MD MSCI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Informed consent, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how heart rate affects blood flow in a major brain artery. Researchers will control participants' heart rates using a temporary device called Electrophysiological Pacing during an already planned heart procedure. The study focuses on individuals undergoing elective heart tests with normal heart pumping ability. Those scheduled for these tests and able to travel to Calgary, Canada, may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance understanding of cardiovascular health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that electrophysiological pacing is safe for heart rate control?

Research has shown that the safety of using a device to control heart rate, known as electrophysiological pacing, has improved over time. Studies indicate that safety measures in heart procedures have enhanced as more procedures are performed.

However, temporary pacing carries some risks, such as the wire moving out of place or causing harm to the heart. Despite these risks, advancements in technology have reduced some complications.

For those considering joining a trial involving this treatment, these findings are helpful. They suggest that while potential risks exist, the safety of these procedures has generally improved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about electrophysiological pacing for controlling heart rate in cerebrovascular conditions because it offers a precise way to manage heart rhythms by directly influencing the heart's electrical activity. Unlike traditional medications that may take time to adjust and affect the entire body, this method targets the heart specifically, potentially leading to quicker and more controlled outcomes. This precision could improve blood flow dynamics in the brain, offering a novel approach to enhancing cerebrovascular health.

What evidence suggests that electrophysiological pacing is effective for controlling heart rate in cerebrovascular physiology?

Research has shown that electrophysiological pacing can safely control heart rate. Studies have found that this temporary pacing often helps patients with slow heart rates by stabilizing their heart rhythm. It improves blood flow by better timing heartbeats and can reliably detect and adjust to the heart's natural rhythm. This trial will explore its potential to manage blood flow in the brain. ^{1 3 6 7 8}

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, scheduled for elective heart rhythm studies where they'll get temporary pacing wires in the right atrium. Participants must consent to the study and be able to visit the Cardiac Electrophysiology Lab in Calgary, Canada.

Inclusion Criteria

I am scheduled for a heart rhythm test that involves placing pacing wires in the right side of my heart.

Able and willing to provide informed consent

I am either male or female.

Exclusion Criteria

Unable or unwilling to provide informed consent

Other factors which in the investigator's opinion would prevent the participant from completing the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Electrophysiological Study

Participants undergo high right atrial pacing at various rates to assess the relationship between heart rate and cerebral blood flow

10-15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the electrophysiological study

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrophysiological Pacing

Trial Overview The study aims to understand how different heart rates affect blood flow in a brain artery by using controlled electrical stimulation of the heart during routine electrophysiological procedures and measuring blood flow with an ultrasound on the head.

How Is the Trial Designed?

Group I: Patients Scheduled for Elective Electrophysiological Study Experimental Treatment 1 Intervention

High right atrial pacing will occur at the following rates for 60 seconds each, with a rest period of at least 60 seconds between pacing runs: * 600 msec (100 bpm) * 500 msec (120 bpm) * 400 msec (150 bpm) * 350 msec (171 bpm)

Electrophysiological Pacing is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electrophysiological Pacing for:

• Arrhythmias
• Heart failure
• Cardiac arrest prevention

Approved in European Union as Electrophysiological Pacing for:

• Arrhythmias
• Heart failure
• Cardiac arrest prevention
• Bradycardia

Approved in Canada as Electrophysiological Pacing for:

• Arrhythmias
• Heart failure
• Cardiac arrest prevention

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

Temporary cardiac pacing techniques have evolved, with methods like transvenous pacing and noninvasive transcutaneous pacing being highlighted for their effectiveness; however, noninvasive pacing can cause discomfort for unsedated patients.

In patients with implanted pacemakers, temporary pacing can either improve or worsen heart function, necessitating careful preoperative management to avoid complications, such as reprogramming rate-responsive functions and deactivating defibrillators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac pacemakers and implantable cardioverter-defibrillators in the perioperative phase]. Kemnitz, J., Peters, J.[2007]

In a study of 605 patients with a history of high ventricular pacing, 11.7% developed persistent atrial tachyarrhythmias (AT/AF) after 2 years, indicating a significant risk associated with long-term ventricular pacing.

Factors such as prior AT/AF and a ventricular pacing percentage of 10% or more in the first 3 months were identified as independent predictors for developing persistent AT/AF, suggesting that minimizing right ventricular pacing could be beneficial, especially in patients with normal AV conduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between ventricular pacing and persistent atrial fibrillation in patients indicated to elective pacemaker replacement: Results of the Prefer for Elective Replacement MVP (PreFER MVP) randomized study. Ricci, RP., Botto, GL., Bénézet, JM., et al.[2016]

Dual chamber pacing can significantly improve exercise ability in patients with atrioventricular block who maintain adequate sinus node function, compared to fixed-rate ventricular pacing.

For patients with chronotropic failure or atrial fibrillation, rate-responsive pacing using various sensors (like pH and respiratory rate) allows for adjustments in pacing rates based on metabolic needs, enhancing their overall cardiac function during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Biosensors and rate-responsive cardiac pacing]. Rodríguez García, J., Silvestre García, J., Coma Samartín, R., et al.[2006]

Ultrasound-guided temporary cardiac pacing was successfully performed in 94% of the 54 patients studied, demonstrating its feasibility and safety without serious complications.

The procedure had a mean execution time of about 11.3 minutes and required fewer resources compared to traditional methods, making it a potentially advantageous alternative for urgent cardiac pacing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Temporary emergency cardiac pacing under continuous echocardiographic control. Feasibility and safety of the procedure without using fluoroscopy]. Pinneri, F., Mazza, A., Garzaro, L., et al.[2006]

Temporary right atrial pacing can be an effective acute treatment for both bradyarrhythmias and tachyarrhythmias in patients experiencing cardiogenic shock.

This method helps restore atrioventricular synchrony, which is crucial for improving cardiovascular hemodynamics in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of atrial temporary pacing as an acute treatment for bradyarrhythmias and tachyarrhythmias in the intensive care setting with preservation of atrioventricular synchrony. Pang, B., Everest, E., McGavigan, AD.[2018]

Transcutaneous cardiac stimulation was successfully used on eight neurocritical patients as a non-invasive alternative to traditional intravenous pacing, proving to be both safe and effective.

The only side effect reported was minor discomfort in conscious patients, highlighting the technique's overall safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Noninvasive temporary cardiac pacemaker in neurologic intensive care patients]. Hund, E., Rieke, K.[2015]

Electrical pacing is a crucial technique for treating tachycardias, especially when drug therapy fails, and its effectiveness depends on understanding the specific mechanism of the tachycardia.

Pacing near the origin of the tachycardia can enhance suppression, and various pacing methods can improve heart performance or slow down the heart rate without eliminating ectopic pacemaker activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tachycardias and electrical pacing. Cohen, HC., Arbel, ER.[2019]

Electronic pacing is an effective treatment for patients experiencing slow ventricular heart rates, providing options for both temporary and permanent solutions.

The choice of pacing mode (epicardial vs. endocardial, fixed vs. demand) is tailored to the individual patient's clinical condition and response to treatment, ensuring optimal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in artificial pacemakers. Bilitch, M., Lau, FK., Cosby, RS.[2018]

Recent advancements in cardiac pacing technology have shifted from outdated mercury-zinc batteries to more efficient lithium, rechargeable, and isotopic power sources, enhancing the reliability and longevity of pacing systems.

While ventricular pacing remains the standard treatment for symptomatic bradycardia, there is ongoing research into experimental pacing systems that may help manage tachyarrhythmias, indicating a potential expansion of pacing applications in cardiac care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac pacing. Smyth, NP.[2019]

In a study of 152 patients undergoing pacemaker implantation, those with symptoms of cerebral hypoperfusion had a higher prevalence of significant stenosis in carotid arteries compared to asymptomatic patients (32% vs. 16%).

Patients with a second degree atrioventricular block and no atherosclerotic lesions had the lowest risk of experiencing symptoms like syncope, suggesting that ultrasonographic evaluation of carotid and vertebral arteries could be crucial for symptomatic patients before pacemaker surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flow disturbances in carotid and vertebral arteries in symptomatic patients referred for pacemaker implantation. Dabrowski, R., Maciag, A., Kowalik, I., et al.[2016]

Temporary cardiac pacing is an effective treatment for various arrhythmias, with atrial pacing being a safer and potentially more effective option than the more commonly used right ventricular pacing.

There are three distinct methods of pacing—interruption, overdrive suppression, and rapid atrial stimulation—each tailored to specific types of arrhythmias, making pacing particularly beneficial for acute recurrent arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of pacemaking for the treatment of acute arrhythmias. 2. Preston, TA.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12130153/

Temporary Pacing for Electric Cardiac Stimulation and ... Neonates may require temporary pacing due to hemodynamic instability secondary to bradycardia or congenital heart block.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2058534923000768

Temporary epicardial pacing after cardiac surgery In order to be safe, a pacing system needs to be able to reliably sense the patient's intrinsic rhythm (Fig. 3) so as to avoid an R-on-T phenomenon. In order to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10770809/

The effectiveness and safety of temporary transvenous cardiac ... The temporary pacing lead routinely is placed into right ventricular (RV), which pose a risk of dislocation and cardiac perforation.

4. academic.oup.com academic.oup.com/europace/article/doi/10.1093/europace/euaf085.529/8141399

Safety and effectiveness of adapted definitive pacemakers to ... Effectiveness measures, including electrode impedance, R-wave sensing, and pacing thresholds, were collected every other day. Complications like ...

5. innovationsincrm.com innovationsincrm.com/cardiac-rhythm-management/articles-2019/may/1432-temporary-permanent-vs-conventional-pacemakers

A Review of Temporary Permanent Pacemakers and ... Temporary cardiac pacing is commonly used in patients with life-threatening bradycardia and serves as a bridge to implantation of a permanent pacemaker (PPM).

6. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X25004007

Electrophysiological Implications of Contemporary Pacing ... The smaller, closely spaced electrodes detect a relatively small QRS and a larger T wave, leading to a narrower safety window and an increased ...

7. ahajournals.org ahajournals.org/doi/10.1161/circep.108.764621

Cardiac Pacing | Circulation: Arrhythmia and ... The basis for activity controlled rate variable cardiac pacemakers: an analysis of mechanical forces on the human body induced by exercise and environment.

8. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)00355-2/abstract

Trends in safety of catheter-based electrophysiology ... Despite an increase in cardiac electrophysiology procedures, procedural safety has improved over time. Keywords. Safety · Outcomes · Cardiac ...