Pacing for Fainting
(Pacing_SV Trial)
Recruiting in Palo Alto (17 mi)
Overseen bySatish R Raj, MD MSCI
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Calgary
Disqualifiers: Cardiac resynchronization device, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
14678How 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.
19101112Eligibility 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.
I am between 18 and 70 years old.
Exclusion Criteria
I need a device to help my heart beat in sync.
Unable or unwilling to provide informed consent
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of CalgaryCalgary, Canada
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Who Is Running the Clinical Trial?
University of CalgaryLead Sponsor
References
[Syncope and fainting in patients with a cardiac pacemaker]. [2009]When a patient with a cardiac pacemaker presents with syncope or faintness, one's first thought should be failure of the pacemaker. If the abnormality is not apparent, the patient needs a full cardiological investigation, including "active" electrocardiographic recordings: magnet test, programming, or even Holter monitor should be performed in order to exclude the responsibility of the pacemaker. Modern pacemakers can fail and cause syncope, especially if they have been inadequately or incorrectly regulated. The so-called physiological (double chamber) pacemakers can induce dangerous arrhythmias. Programming of the pacemaker can avoid further operation and can relieve the syncope: acceleration to prevent twisting of the apex, increase in the power of the impulses to eliminate the defects in stimulation due, for example, to a rise in the threshold. The syncope may also be caused by an extracardiac cause: associated pathology or useless implantation; the simplicity of implantation techniques sometimes means that pacemakers are implanted in inappropriate cases.
Effect of dual-chamber pacing with automatic rate-drop sensing on recurrent neurally mediated syncope. [2022]We tested the hypotheses that a dual-chamber pacemaker that paces when intrinsic rate drops abruptly would reduce the number of syncopal spells and improve the quality of life in patients with highly recurrent neurally mediated syncope. Twelve patients with highly frequent neurally mediated syncope and at least 1 syncopal spell after tilt testing received dual-chamber pacemakers with automatic rate-drop sensing. The pacemakers were implanted 17+/-26 months after tilt testing, and the patients then were followed for 12+/-2 months. We compared the time to the first recurrence of syncope, syncope frequency, and quality of life for the 2 periods between tilt testing and pacemaker implantation, and between implantation and last follow-up. Only 6 of 12 patients fainted after pacemaker insertion. The median time to syncope recurrence before and after pacing was 7 days and 5.3 months, respectively. The geometric mean frequency of faints before and after pacing was 5.0 spells/month (95% confidence interval 2.7 to 9.2) and 0.30 spells/month (95% confidence interval 0.2 to 0.4), p
Antiarrhythmic therapy in the elderly: pacemakers and drugs. [2013]Investigations of syncope often fail to demonstrate any abnormality. However, in view of the ease of permanent pacemaker implantation and the potential dangers of recurrent syncope, patients with this symptom should receive pacemaker therapy. In general, acute therapy of any tachyarrhythmia associated with hemodynamic collapse consists of DC cardioversion, but skillful use of drug therapy and, occasionally, pacemaking are also highly important in preventing recurrences.
Pacing therapy in the management of unexplained syncope: a tertiary care centre prospective study. [2021]Pacemaker (PM) therapy is effective when syncope is associated with bradycardia, but syncope recurrences and fall injuries after PM implantation may occur. We aimed to survey indications and outcomes of PM implantation, following evaluation of unexplained syncope.
Permanent pacemaker implantation in unexplained syncope patients with electrophysiology study-proven atrioventricular node disease. [2022]Syncope, whose cause is unknown after an initial assessment, has an uncertain prognosis. It is critical to identify patients at the highest risk who may require a pacemaker and to identify the cause of recurrent syncope to prescribe proper therapy. The aim of this study was to evaluate the effect of permanent pacing on the incidence of syncope in patients with unexplained syncope and electrophysiology study (EPS)-proven atrioventricular (AV) node disease.
Persisting symptoms despite permanent pacing. Incidence, causes, and follow-up. [2019]Persisting symptoms, consisting of palpitations, dizziness, or syncope, were found in 49 of 570 consecutively followed patients (8.6 percent) with permanent pacemakers (PM). Among 540 patients with ventricular PM, 19 had syncope and 24 dizziness; among 30 patients with dual-chamber PM, five had palpitations and one dizziness. Symptoms were PM-related in 17, caused by tachyarrhythmias in 12, of noncardiac origin in 16, and of unknown origin in four patients. Holter monitoring was necessary for evaluating the persisting symptoms in 36 patients and helpful in 32 studies (89 percent). Symptoms were relieved in all patients with PM-related causes but only in 6/16 patients (38 percent) with syncope or dizziness of noncardiac origin despite various therapeutic measures. In patients with either documented tachyarrhythmias or unknown cause of syncope or dizziness, antiarrhythmic drugs led to symptomatic improvement in 11 of 12 treated patients during an average follow-up of 15 months. We concluded that: (1) persistent syncope, dizziness, or palpitations occurred in 8.6 percent of 570 patients after PM-implantation; (2) symptoms were more frequent but less severe in patients with dual-chamber PM than in those with ventricular PM; (3) tachyarrhythmias as a possible cause of symptoms were found in 25 percent of patients; (4) symptomatic improvement was noted in 28 of 29 patients when a PM-related cause or tachyarrhythmias were treated.
A case report of inappropriate inhibition of ventricular pacing due to a unique pacemaker electrogram storage feature. [2022]Modern permanent pacemakers (PPMs) have individual features designed to identify cardiac rhythm abnormalities and improve their performance. Inappropriate pacing inhibition may be an undesired outcome from these features and cause symptoms in patients who require frequent pacing, leading to dizziness, and syncope. Inappropriate inhibition can be difficult to identify in circumstances that are intermittent and difficult to reproduce.
Pacer-induced tachycardia associated with an atrial synchronous ventricular inhibited (ASVIP) pulse generator. [2019]A 68-year-old white male underwent permanent pacemaker implantation with an atrial synchronous ventricular inhibited pulse generator (Medtronic model 2409) because of syncope and abnormal H-V interval of 70 ms. Paroxysmal bouts of pacemaker associated tachycardia were subsequently recorded on several occasions, initiated and terminated by spontaneous ventricular premature beats. The mechanism for the occurrence of the tachyarrhythmia is discussed in detail and the functional characteristics of the pulse generator are described. Replacement of the unit with a different pacer device prevented further occurrence of the arrhythmia.
An overview of permanent cardiac pacing. [2011]A permanent cardiac pacemaker is an implantable device that maintains the patient's heart rate by electrically stimulating the heart muscle when the natural regulating mechanisms fail. This article focuses on the indications for permanent cardiac pacing, general technical concepts and care of the patient undergoing this procedure.
Pacemakers. [2019]A pacemaker is a battery powered device which generates electrical discharges when the natural mechanism of the heart : fails. It may be fixed rate or demand and is QRS inhibited. The system may be for : temporary or permanent use. The first permanent pacemaker was implanted in Switzerland in 1958 in a patient, Arne Larsson, who had suffered from increasingly irregular cardiac rhythm for some years.
Impact of bundle branch block morphology on outcomes of patients with syncope and bifascicular block: A SPRITELY (POST 3) substudy. [2023]Permanent pacing is often considered for patients with syncope and bifascicular block.
Parameters associated with one-year mortality and in-hospital adverse events in patients after emergency pacemaker implantation. [2017]Permanent cardiac pacing is the treatment of choice for severe and symptomatic bradycardia. Patients undergoing emergency pacemaker implantation are stabilised earlier by the insertion of a temporary emergency pacing lead, and they experience more comorbidities than with planned admissions.