Angiography + ECG for Heart Disease

((ANGEL-BBP) Trial)

Overseen By Pugazhendhi Vijayaraman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pugazhendhi Vijayaraman

Disqualifiers: Pregnant, Atrial fibrillation, Renal dysfunction, others

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

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for placing a wire in the Bachmann bundle of the heart during pacemaker or defibrillator implant procedures. Researchers compare two methods: one uses contrast dye and x-ray, while the other includes an electrocardiogram (ECG). Both methods are commonly used and FDA-approved. Ideal candidates for this trial are individuals who need a new pacemaker or defibrillator and can follow study procedures. As an unphased trial, this study allows participants to contribute to advancing medical techniques for heart procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these methods for wire placement are safe?

Research shows that Bachmann Bundle Pacing is generally safe and well-tolerated. Studies have found that placing the pacemaker lead in the Bachmann bundle is a practical and safe choice for many patients. This method has a high success rate and can improve heart function by mimicking normal heart rhythms.

The trial employs two standard methods: angiography (a type of x-ray) and ECG (electrocardiogram). These are common, FDA-approved techniques for placing leads in the heart. Recent studies have not reported any major side effects from these methods.

Overall, evidence suggests that these procedures are safe for individuals requiring pacemaker or defibrillator implants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach for diagnosing and managing heart disease using Angiography combined with ECG. Unlike traditional methods that often rely solely on angiography to visualize blood vessels, this trial investigates the additional insights that can be gained by integrating ECG, which tracks electrical activity in the heart. This combination could potentially offer a more comprehensive view of heart health, leading to earlier detection of issues and more personalized treatment plans. By focusing on Bachmann Bundle Pacing, researchers hope to find out if this method improves heart function and patient outcomes compared to existing diagnostic strategies.

What evidence suggests that this trial's methods could be effective for heart disease?

Research has shown that Bachmann bundle pacing can better imitate normal heart function, potentially avoiding problems often seen with traditional pacing methods. Specifically, it may help reduce the risk of atrial fibrillation, an irregular heartbeat, over time. Studies have found that pacing from this area improves heart function by better timing the heart's muscle contractions. Additionally, placing leads in this location has proven safe and feasible, with successful placement in most patients. Overall, the Bachmann bundle approach shows promise for better results in heart pacing treatments.

Note: The current trial focuses on comparing angiography alone versus angiography combined with ECG for heart disease and does not include Bachmann bundle pacing as a treatment arm. ^{1 2 3 6 7}

Who Is on the Research Team?

Pugazhendhi Vijayaraman, MD

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

This trial is for individuals scheduled to receive a permanent pacemaker or defibrillator and require wire placement in the heart's right atrium. Participants must be suitable for having wires placed alternatively in the Bachmann bundle.

Inclusion Criteria

Patient with an indication for permanent pacemaker or ICD utilizing atrial pacing lead

I am willing and able to follow the study rules and attend all required visits.

I am over 18 years old.

Exclusion Criteria

Pregnant

I am unable to understand or sign the consent form.

My kidney function is impaired with a Creatinine level above 3.0 mg/dl.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implant Procedure

Participants undergo the implant procedure where the pacing lead is placed using angiography and/or ECG guidance

Perioperative

1 visit (in-person)

Follow-up

Participants are monitored for atrial pacing parameters and P-wave morphology and duration

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bachmann Bundle Pacing

Trial Overview The study compares two FDA-approved methods of placing a wire in the Bachmann bundle during device implantation: one using angiography with contrast dye and x-ray, and another adding ECG to this process.

How Is the Trial Designed?

Group I: Angiography only Experimental Treatment 1 Intervention

Group II: Angiography and ECG Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Pugazhendhi Vijayaraman

Lead Sponsor

Trials

2

Recruited

120+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Citations

1. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)02281-1/abstract

Bachmann bundle pacing Progression of paroxysmal to persistent atrial fibrillation during atrial pacing at Bachmann's bundle versus right atrial appendage: a 2-year follow-up

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637835/

Alternative atrial pacing site to improve cardiac function Pacing from Bachmann's bundle closely reproduces normal physiology and has the potential to avoid the electromechanical dysfunction associated ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666501824000977

Short-term safety and feasibility of a practical approach to ... Routine placement of leads in the HRAS is a feasible and safe alternative to standard RAA pacing, allowing for BBP in 72% of patients.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04749836

Outcomes and Safety of Various Conduction System ... Implant success rate, specific implant characteristics, procedural complications, electrical parameters and clinical outcomes will be analyzed at implantation, ...

5. jacc.org jacc.org/doi/10.1016/j.jaccas.2025.104421

Comprehensive Conduction System Pacing as ... - JACC In a computational model, Bachmann bundle pacing has been shown to lower left atrial filling pressures by optimizing the timing between left ...

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02709-2/abstract

Accelerated Bachmann bundle area pacing for atrial ... Accelerated BBAP was found to reduce the NT-proBNP and was accompanied by an improvement in the diastolic function and exercise capacity.

7. academic.oup.com academic.oup.com/europace/article/27/Supplement_1/euaf085.539/8141691

A novel approach for Bachmann's bundle pacing implantation ... Clinical impact of Bachmann's bundle pacing defined by electrocardiographic criteria on atrial arrhythmia outcomes ... Pacing: Data from ...