Intra-procedural Transthoracic Echocardiogram for Heart Failure

(EC-LBBAP Trial)

Overseen By Pugazhendhi Vijayaraman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

Disqualifiers: Pregnant, Informed consent, Others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether using a heart ultrasound during pacemaker implantation helps doctors place the wires more accurately and quickly. It also seeks to determine if this method reduces the time needed for x-ray imaging during the procedure. Participants will undergo a heart ultrasound during their pacemaker implant and attend follow-up visits to monitor heart health. This trial may suit individuals who need a pacemaker or similar heart device and are willing to participate in all study activities. As an unphased trial, it offers participants the chance to contribute to innovative research that may enhance future heart procedures.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the study coordinators or your doctor.

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 is best to discuss this with the study team or your doctor.

What prior data suggests that the use of heart ultrasound during pacemaker implantation is safe?

Research has shown that using a heart ultrasound during pacemaker implantation is safe. Studies have found that this method often results in less x-ray exposure compared to other techniques. Although the ultrasound method reduces certain risks, such as those related to wires, issues like bleeding at the procedure site can still occur. However, these problems are uncommon. Overall, using a heart ultrasound in these procedures is well-tolerated, with most patients experiencing no significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using intra-procedural transthoracic echocardiograms during pacemaker implants to better manage heart failure. Unlike standard protocols, which typically don't involve real-time imaging, this method uses ultrasound technology during the procedure. This can potentially provide immediate feedback and improve precision in pacemaker placement. By enhancing the accuracy of pacemaker implants, this approach could lead to better outcomes for patients with heart failure.

What evidence suggests that using a heart ultrasound during pacemaker implantation is effective for heart failure?

This trial will compare different methods of using heart ultrasounds during pacemaker implants. Research has shown that heart ultrasounds can help doctors better visualize wire placement. In this trial, one group will receive a heart ultrasound using a handheld device during the procedure, while another group will receive a standard heart ultrasound. A study found that combining a 3D heart ultrasound with regular imaging improved the view of the pacemaker, making wire placement more accurate. This method might also speed up the procedure by reducing x-ray time. Early findings suggest this could lead to a safer and quicker pacemaker implantation process, potentially benefiting those with heart failure. ^{2 3 6 7 8}

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 patients needing a permanent pacemaker or ICD with conduction system pacing lead for slow heart rate or to coordinate heartbeats. They must be willing to follow the study's procedures and be available throughout its duration. It's not for those who can't consent, are pregnant, or in another study that could affect results.

Inclusion Criteria

You have a pacemaker or Implantable Cardioverter Defibrillator (ICD) for heart rhythm issues.

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

Exclusion Criteria

Enrolled in a concurrent study that may confound the results of this study

Inability to provide informed consent

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implant Procedure

Participants undergo pacemaker implantation with echocardiogram guidance

1 day

1 visit (in-person)

Post-Implant Follow-up

Participants have a physical exam, ECG, and device interrogation at 2 weeks and 3 months post-implant

3 months

2 visits (in-person)

Long-term Follow-up

Participants are monitored for long-term outcomes and procedural success

15 months

What Are the Treatments Tested in This Trial?

Interventions

• Intra-procedural Transthoracic Echocardiogram

Trial Overview The study observes if using a heart ultrasound during pacemaker implantation helps doctors place wires accurately, reduces procedure time, and cuts down on x-ray use. Participants will undergo exams, ECGs, ultrasounds during implantation, and device checks post-implant.

How Is the Trial Designed?

Group I: ECLBBAP handheld participant Experimental Treatment 1 Intervention

A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure

Group II: EC-LBBAP Participant Experimental Treatment 1 Intervention

A heart ultrasound will be used during a pacemaker implant procedure

Group III: Control participant Active Control 1 Intervention

A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm.

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

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

Published Research Related to This Trial

Transvenous lead extraction is a crucial procedure for managing cardiac devices, and using intracardiac echocardiography alongside traditional fluoroscopy enhances the safety and efficacy of the procedure.

Intracardiac echocardiography helps identify complications and lead-tissue adherence, allowing for better risk assessment and tool selection during lead removal, ultimately improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracardiac Echocardiography During Transvenous Lead Extraction. Schaller, RD., Sadek, MM.[2021]

Using ultrasound guidance for transvenous pacemaker wire insertion in the right ventricle offers significant advantages over traditional fluoroscopy, including real-time visualization and avoidance of radiation, enhancing safety during the procedure.

This technique allows for rapid deployment and early detection of complications, such as cardiac tamponade, making it a valuable skill for anesthesiologists in perioperative settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Subcostal Echocardiographic Views to Guide the Insertion of a Right Ventricular Temporary Transvenous Pacemaker-Description of the Technique. Sjaus, A., Fayad, A.[2020]

Intracardiac echocardiography is a crucial real-time imaging tool that enhances the safety and effectiveness of various invasive cardiac procedures by providing detailed images of cardiac structures during operations.

This technique is particularly beneficial when traditional imaging methods, like transthoracic echocardiography, are inadequate, allowing for procedures such as device implantation, electrophysiological mapping, and biopsies to be performed with greater precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology update: intracardiac echocardiography - a review of the literature. Vitulano, N., Pazzano, V., Pelargonio, G., et al.[2020]

Intracardiac echocardiography was successfully used in 53 patients to guide transseptal puncture for radiofrequency catheter ablation, allowing for clear visualization of cardiac structures and ensuring accurate placement of the transseptal dilator.

The procedure was highly effective, with a 96% success rate on the first attempt and no complications reported, demonstrating both the safety and efficacy of using echocardiography in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracardiac echocardiography to guide transseptal left heart catheterization for radiofrequency catheter ablation. Daoud, EG., Kalbfleisch, SJ., Hummel, JD.[2019]

Intracardiac echocardiography can effectively diagnose pacemaker lead infections when transesophageal echocardiography fails to provide clear results, as demonstrated in a specific patient case.

This case highlights the importance of intracardiac echocardiography as a valuable tool in diagnosing infective endocarditis, particularly in challenging situations where other imaging methods are inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracardiac echocardiography in the detection of pacemaker lead endocarditis. Dalal, A., Asirvatham, SJ., Chandrasekaran, K., et al.[2019]

The study shows that pacing the left bundle branch and atrial septum can be successfully performed using transthoracic echocardiography (TTE) without the need for fluoroscopic guidance.

This technique may be particularly beneficial for guiding pacemaker implantation in certain patients, including pregnant women, enhancing safety by reducing radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transthoracic echocardiography-guided left bundle branch pacing without fluoroscopic guidance: A case report. Tan, K., Deng, X., Wang, S., et al.[2021]

The study demonstrated that using an external stimulator to trigger an implanted pacemaker during stress echocardiography is both feasible and safe, with no adverse effects reported among the 15 patients tested.

This method allows for effective diagnosis of coronary artery disease in patients with pacemakers without incurring additional costs, making it a practical option for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety of noninvasive pacemaker stress echocardiography with externally triggered stimulation. Gianfranchi, L., Bettiol, K., Pacchioni, F., et al.[2016]

Citations

1. withpower.com withpower.com/trial/phase-heart-failure-2023-6af05

Intra-procedural Transthoracic Echocardiogram for Heart Failure ... The goal of this observational study is to learn more about whether or not the use of heart ultrasound during pacemaker implantation is helpful.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/51/NCT05646251/Prot_SAP_000.pdf

Research Protocol – 2022-0917 2D transthoracic echo at implant. During implant procedure, transthoracic echo windows will be identified and documented: Parasternal short and long axis ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9123317/

Novel use of 3-dimensional transthoracic ... Use of 3-dimensional transthoracic echocardiography as an adjunct to fluoroscopy during implantation can improve visualization of the pacemaker device in ...

4. jacc.org jacc.org/doi/10.1016/j.jacep.2022.06.023

Echocardiogram-Guided Leadless Pacemaker Implantation The endpoints of the study were 1) acute procedure success; 2) procedure characteristics (procedure and fluoroscopy time); 3) procedure-related ...

5. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02610-4/fulltext

Step-by-step approach to ultrasound-guided leadless ... This article provides a technical overview and step-by-step instructions on using ultrasound to guide LP implantation. Keywords. Ultrasound ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9877395/

Exploratory use of intraprocedural transesophageal ... This proof-of-concept study demonstrates the use of TEE cardiac landmarks and electrocardiographic gating to guide optimal LP placement.

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.122.011408

Intracardiac Echocardiography–Guided Implantation for ... This study was conducted to evaluate the feasibility of implanting an LBB pacing lead in the proximal LBB (PLBB) guided by intracardiac echocardiography (ICE).

8. sciencedirect.com sciencedirect.com/science/article/pii/S0735109709040650

Percutaneous Pacemaker and Implantable Cardioverter ... We describe the feasibility, safety, and clinical outcomes of percutaneous lead extraction in patients at a tertiary care center who had intracardiac ...