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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this observational study is to learn more about whether or not the use of heart ultrasound during pacemaker implantation is helpful. The main questions this aims to answer are: 1. Does this help the doctors with figuring out the wire location during implantation? 2. Does this reduce the wire placement procedure time? 3. Does this reduce the x-ray imaging time during the procedure? Participants will be asked to: 1. Have a physical exam and Echocardiogram (ECG) at initial visit, 2 weeks post implant, and 3 months post implant. 2. Have a urine pregnancy test (if applicable) 3. Have a heart ultrasound during implant procedure 4. Answer questions related to heart failure symptoms to see what stage of heart failure is present 5. Have device interrogation (a wand placed over the chest to see that the device is working properly) at a visit 2 weeks post implant and at 3 months post implant.

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 data supports the idea that Intra-procedural Transthoracic Echocardiogram for Heart Failure is an effective treatment?

The available research shows that using echocardiography, a type of heart ultrasound, can help guide procedures like pacemaker implantation without the need for radiation. This is especially useful for certain patients, such as pregnant women. While the studies focus on different uses of echocardiography, they highlight its ability to provide real-time images, which can help doctors place devices more accurately and safely. This suggests that echocardiography can be an effective tool in heart procedures, offering advantages like avoiding radiation and detecting complications early. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Intra-procedural Transthoracic Echocardiogram for Heart Failure?

A case study shows that transthoracic echocardiography (TTE) can guide pacemaker implantation without using fluoroscopy (X-ray guidance), which may be beneficial for certain patients, like pregnant women. This suggests that TTE can effectively assist in procedures involving the heart, potentially improving safety and outcomes. ^{1 2 3 4 5}

What safety data exists for intra-procedural transthoracic echocardiogram in heart failure treatment?

The safety of intra-procedural transthoracic echocardiogram (TTE) has been demonstrated in various contexts. A case report showed the feasibility of using TTE to guide left bundle branch pacing without fluoroscopic guidance, suggesting it could be a safe alternative for pacemaker implantation, especially in pregnant women. Additionally, subcostal echocardiographic views have been used to guide the insertion of right ventricular temporary transvenous pacemakers, offering advantages such as rapid deployment, avoidance of radiation, and real-time visualization, which enhance safety by allowing early detection of complications. These studies indicate that TTE is a safe and effective tool in guiding cardiac procedures. ^{1 3 5 6 7}

Is intra-procedural transthoracic echocardiogram safe for use in humans?

Intra-procedural transthoracic echocardiogram (a heart ultrasound) is generally considered safe for guiding procedures like pacemaker implantation and other cardiac interventions. It avoids radiation exposure and allows real-time visualization, which helps in early detection of potential complications. ^{1 3 5 6 7}

Is the treatment in the trial 'Intra-procedural Transthoracic Echocardiogram for Heart Failure' a promising treatment?

Yes, the treatment is promising because it provides real-time images during heart procedures, helping doctors see the heart better and make more accurate decisions. It can also help avoid the need for more invasive procedures and improve safety during heart treatments. ^{2 3 4 5 7}

How does the treatment using intra-procedural transthoracic echocardiogram for heart failure differ from other treatments?

Intra-procedural transthoracic echocardiogram for heart failure is unique because it uses real-time imaging to guide heart procedures, providing detailed images without the need for invasive techniques or general anesthesia. This approach can improve the precision and safety of heart failure treatments by allowing doctors to see the heart's structures and function during the procedure. ^{2 3 4 5 7}

Research Team

Pugazhendhi Vijayaraman, MD

Principal Investigator

Geisinger Clinic

Eligibility Criteria

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

Inability to provide informed consent

Pregnant

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: EC-LBBAP Participant Experimental Treatment 1 Intervention

A heart ultrasound will be used during a pacemaker implant procedure

Group II: 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

Findings from Research

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transthoracic echocardiography-guided left bundle branch pacing without fluoroscopic guidance: A case report. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intracardiac Echocardiography During Transvenous Lead Extraction. [2021]

3. United States 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Intracardiac echocardiography in the detection of pacemaker lead endocarditis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Intracardiac echocardiography to guide transseptal left heart catheterization for radiofrequency catheter ablation. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility and safety of noninvasive pacemaker stress echocardiography with externally triggered stimulation. [2016]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Technology update: intracardiac echocardiography - a review of the literature. [2020]