Augmented Pacing for Bradycardia

Overseen By Jonah D Garry, M.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Single chamber ICD, Ventricular tachycardia, Hemodynamic instability, Mechanical support, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adjusting the backup pacing rate on pacemakers benefits individuals with slow heart rates, pacemakers, and heart problems. The researchers aim to determine if setting the pacemaker to a faster rate of 100 beats per minute improves the heart's ability to pump blood compared to the usual 75 beats per minute setting. Participants include those already in the heart intensive care unit with a pacemaker and other specific heart monitoring tools, particularly if they have recently experienced a slow heart rate. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance heart treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since participants must be receiving a vasopressor or inotrope, it seems likely that some medications will continue.

What prior data suggests that this pacing protocol is safe for patients with bradycardia?

Research has shown that treatments for bradycardia, a slow heart rate, are generally safe. However, these treatments can sometimes cause other heart rhythm problems, such as a fast heart rate. While the treatment is usually well-tolerated, there is a chance it might lead to some heart rhythm issues.

A review of current data indicates that these treatments do not significantly increase the overall risk of complications. Studies suggest that certain types of treatments remain safe over several months. This means that while some risks exist, they are uncommon and usually manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Augmented Pacing for Bradycardia trial because it explores a new approach to managing bradycardia, a condition characterized by abnormally slow heart rates. Unlike traditional pacemakers that maintain a fixed pacing rate, this trial evaluates the effects of adjusting the backup pacing rates between 75 bpm and 100 bpm. By alternating pacing rates, researchers hope to better understand how varying heart rates might optimize heart function and patient outcomes. This could potentially lead to more personalized and dynamic pacing strategies, providing a fresh perspective on managing slow heart rhythms.

What evidence suggests that this pacing rate change is effective for improving hemodynamics in bradycardia?

This trial will compare different pacing rates for pacemakers in patients with bradycardia. Studies have shown that increasing the backup pacing rate in pacemakers can improve heart function. Research indicates that setting a pacemaker to a higher rate, such as 100 beats per minute, may enhance blood flow, which is crucial for patients with heart issues like bradycardia. Specifically, previous patients with pacemakers experienced better heart performance when the pacing rate increased. This suggests that faster pacing helps the heart pump blood more effectively. Such improvements in heart function are vital for individuals with cardiogenic shock, where the heart struggles to supply enough blood to the body. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 in the Cardiovascular Intensive Care Unit (CVICU) with a permanent pacemaker and slow heart rate, who are on specific heart medications for at least 4 hours. They must have a special catheter placed to measure heart function and an average heart rate of 75 bpm or less.

Inclusion Criteria

I have a pacemaker or ICD that can be set to 100 bpm.

I have a working pulmonary artery catheter with a thermistor.

I have been on medication to support my heart or blood pressure for at least 4 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants are exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate

1 day

In-hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Backup Pacing Rate Change

Trial Overview The study tests if increasing the backup pacing rate of a pacemaker to 100 beats per minute can improve heart function compared to the usual setting of 75 beats per minute in patients with cardiogenic shock and relative bradycardia.

How Is the Trial Designed?

Group I: Standard Pacing (75 bpm) then Augmented Pacing (100 bpm) Experimental Treatment 1 Intervention

Backup pacing rate will be set to 75 bpm first then 100 bpm second

Group II: Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm) Experimental Treatment 1 Intervention

Backup pacing rate will be set to 100 bpm first then 75 bpm second

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. withpower.com withpower.com/trial/augmented-pacing-for-bradycardia-2328f

Augmented Pacing for Bradycardia Trial Overview The study tests if increasing the backup pacing rate of a pacemaker to 100 beats per minute can improve heart function compared to the usual ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1767518/

Pacing for atrial fibrillation - PMC Pacing at 400 ms and 300 ms were equally effective in preventing ERAF (42%), or delaying its onset (58%). APB density was reduced from 16.4/min to 3.4/min with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1547527110005643

Atrial pacing or ventricular backup–only ... Overall HFH/HFUC rates were slightly higher during atrial pacing (event-free rate 85.4% vs. 86.4% for ventricular backup pacing). Exploratory analyses revealed ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/195648

The Dual Chamber and VVI Implantable Defibrillator ... Objective To determine the efficacy of dual-chamber pacing compared with backup ventricular pacing in patients with standard indications for ICD implantation ...

5. academic.oup.com academic.oup.com/europace/article/25/5/euad065/7081495

Avoiding unnecessary ventricular pacing is associated with ... Main study endpoints were the incidence of heart failure hospitalizations (HFH), persistent atrial fibrillation (AF), and cardiac death.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10942895/

Anti-bradycardia pacing—impact on patients with HFpEF This review aims to assess current data regarding the impact of anti-bradycardia pacing in patients with HFpEF.

7. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)03270-3/fulltext

Conduction system pacing associated with reduced ... CSP was safe with no significant differences in the overall complication rates at 6 months compared with DC RV pacing. •. No significant ...