Anodal Biphasic Pacing for Cardiac Pacing

(ABP Trial)

Overseen By Robert Helm, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Atrial fibrillation, AV block, Ischemic heart disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help the heart beat more effectively, called anodal biphasic pacing (ABP), a type of cardiac pacing. ABP may improve heart function and reduce common issues associated with current pacemaker technology, such as heart inflammation and failure. The trial involves patients undergoing heart procedures or those with pacemakers needing upgrades. Individuals scheduled for heart procedures or pacemaker maintenance might be suitable candidates. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance future cardiac care.

Do I have to stop taking 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 or your doctor.

What prior data suggests that this pacing method is safe?

Research shows that a new method called anodal biphasic pacing (ABP) might be safer than traditional pacemakers. Studies have found that ABP can enhance heart function more effectively than the usual method, which sometimes slows heart signals and can lead to issues like inflammation and heart failure.

Evidence suggests that ABP improves heart function without the same risks. Specifically, ABP has significantly boosted heart muscle performance and reduced stress on the heart. These benefits indicate that ABP could be a safer and more comfortable option for those needing pacemakers. However, researchers are still gathering information on its long-term safety, so it's important to consider this when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about anodal biphasic pacing because it offers a potentially more efficient way to manage cardiac pacing. Unlike traditional pacing methods that rely on unipolar pacing leads, this technique uses a biphasic waveform, which could improve the synchronization of heart contractions. This might lead to better outcomes for patients, especially those undergoing procedures like electrophysiology or cardiac resynchronization therapy. The method could also potentially simplify procedures and enhance the longevity of cardiac devices.

What evidence suggests that anodal biphasic pacing is effective for cardiac pacing?

Research has shown that anodal biphasic pacing (ABP) might improve heart function compared to traditional pacemakers. Traditional pacemakers can sometimes slow heart signals, potentially leading to problems like heart failure. ABP prepares the heart before it beats, which can enhance heart performance. Studies suggest that ABP can synchronize heartbeats and improve heart muscle function, possibly reducing the risk of irregular heartbeats associated with standard pacemakers. Although more research is needed, these early findings indicate that ABP could be a better option. Participants in this trial will be divided into different cohorts to evaluate ABP's effectiveness in various cardiac procedures and conditions. ^{1 5 6 7 8}

Who Is on the Research Team?

Robert Helm, MD

Principal Investigator

Boston Medical Center, Cardiology

Are You a Good Fit for This Trial?

This trial is for individuals who require cardiac pacing. Specific eligibility criteria are not provided, but typically participants would need a diagnosis where pacing is indicated and be in stable condition to undergo the intervention.

Inclusion Criteria

I am scheduled for a heart procedure.

I am scheduled for a generator exchange for my dual chamber heart device and my atrial lead works.

I am scheduled for a new implant or to replace my heart device that helps control my heartbeat.

Exclusion Criteria

Third degree AV block without stable escape rhythm

Not fluent in English

Unable to read in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anodal biphasic pacing (ABP) during interventional cardiac procedures or CIED implant/generator exchange

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Anodal Biphasic Pacing

Trial Overview The study tests anodal biphasic pacing (ABP), a new heart stimulation method that may improve heart function and reduce problems associated with current monophasic cathodal pacing (MCP). Participants will receive ABP to see if it's as effective or better than MCP.

How Is the Trial Designed?

Group I: Cohort C Experimental Treatment 1 Intervention

Patients who are undergoing new implant or generator exchange of CIED with cardiac resynchronization therapy.

Group II: Cohort B Experimental Treatment 1 Intervention

Patients who have pacing indication and are undergoing routine generator exchange of dual chamber cardiac implantable electronic device (CIED).

Group III: Cohort A Experimental Treatment 1 Intervention

Cardiac patients who are undergoing interventional cardiac procedure including electrophysiology (EP) with planned retrograde left ventricular access or diagnostic coronary catheterization.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Rocky Mountain Biphasic

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07173777

NCT07173777 | Cardiac Anodal Biphasic Pacing The goal of this study is to test a new pacing method called anodal biphasic pacing (ABP) to determine if this pacing works as well-or ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10466271/

Cardiac Resynchronisation with Conduction System Pacing CSP is a physiological pacing modality that has been shown to improve clinical, ECG and echocardiographic outcomes in patients with heart failure.

3. academic.oup.com academic.oup.com/ehjopen/article/8166595

a comparative study of anodal ring capture versus unipolar ... This study demonstrated that LBAP-ARC offers superior ventricular synchrony and improved myocardial function compared to unipolar LBAP, ...

4. ahajournals.org ahajournals.org/doi/10.1161/circep.111.965475

Disparity in Left Ventricular Stimulation Among Different ... The goal of cardiac resynchronization therapy (CRT) is to deliver effective, safe, and permanent left ventricular (LV) pacing. Multiple programmable LV pacing ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37307884/

Significance of effective cardiac resynchronization therapy ... The primary and secondary outcomes were heart failure (HF) hospitalization and prevalence of CRT responders, defined as patients with an improvement in LV ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11120080/

Clinical and long term safety outcomes of conduction ... Patients had to complete at least 3 months of follow-up and CSP patients had to pace at least 20% of time at first visit. The outcomes were defined as at least ...

7. patlynk.com patlynk.com/trial/NCT07173777

ABP | Cardiac Anodal Biphasic Pacing in Patients with Non ... The study will measure how well ABP improves heart function compared to cathodal pacing, focusing on finding the best settings for ABP.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39138295

Feasibility, safety and outcomes of conduction system ... The primary endpoint was a composite of heart failure (HF)-hospitalizations, pacing-induced cardiomyopathy requiring cardiac resynchronization ...