Intra-procedural Transthoracic Echocardiogram for Heart Failure

(EC-LBBAP Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Pugazhendhi Vijayaraman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Geisinger Clinic

No Placebo Group

Approved in 1 Jurisdiction

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.

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.

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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.

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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.

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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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Geisinger Clinic Wilkes-Barre, PA

Who Is Running the Clinical Trial?

Geisinger Clinic Lead Sponsor

Medtronic Industry Sponsor

References

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

Transthoracic echocardiography-guided left bundle branch pacing without fluoroscopic guidance: A case report. [2021] This case study demonstrates the feasibility of pacing the left bundle branch and atrial septum under transthoracic echocardiography (TTE) without fluoroscopic guidance. This technique could be useful to guide pacemaker implantation in some patients, especially pregnant women.

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

Intracardiac Echocardiography During Transvenous Lead Extraction. [2021] Transvenous lead extraction is an invaluable procedure within the contemporary management of cardiac implantable electronic devices. Transvenous lead extraction has traditionally been guided by fluoroscopy. Complementary imaging with intracardiac echocardiography can provide valuable additional information, such as identification of complications, lead-adherent echodensities, and sites of lead-tissue adherence. As such, it can be used to aid in risk stratification before lead removal, help to choose tools or techniques, and provide visual monitoring throughout the procedure. Intracardiac echocardiography can be incorporated into the lead extraction workflow of the contemporary electrophysiologist and provide valuable information supporting safety and efficacy.

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] The need for temporary cardiac pacing may occur in emergency and elective situations and may require transvenous right ventricular lead placement. The treatment of bradyarrhythmias presents the most common perioperative emergency indication. Intraoperatively, temporary rapid right ventricular pacing is accepted as a safe, titratable, and highly reliable method to achieve deliberate hypotension, and it has become a routine practice in the anesthetic management of cardiovascular interventions. The navigation of the lead into the right ventricle often requires fluoroscopy to guide placement and to confirm position. Ultrasound guidance has been accepted widely by perioperative physicians as a safe technique for central venous access. Basic ultrasound and transthoracic echocardiographic skills rapidly are becoming integral to anesthesiologists' practice. When used to guide transvenous pacemaker wire insertion, subcostal echocardiographic imaging offers attractive advantages over blind or fluoroscopic placement, including rapid deployment, avoidance of radiation, real-time visualization of the lead in relation to the cardiac structures, and early detection of potential complications, such as tamponade. Although several articles on echocardiographic guidance for transvenous pacing have been published in other acute care specialty fields in the last decade, this is the first description of the technique and of the recommended echocardiographic views in a perioperative context. In addition, a review of the current literature is presented, and the specific advantages and disadvantages of the approach are discussed in this article.

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

Intracardiac echocardiography in the detection of pacemaker lead endocarditis. [2019] At times, infection of pacemaker leads can be difficult to confirm even with transesophageal echocardiography. We describe a patient with pacemaker lead infection where the transesophageal echocardiogram was nondiagnostic, and intracardiac echocardiography made the diagnosis by demonstrating the vegetation on the pacemaker lead. This illustrates a potential role for intracardiac echocardiography in infective endocarditis when transesophageal echocardiography is nondiagnostic.

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

Intracardiac echocardiography to guide transseptal left heart catheterization for radiofrequency catheter ablation. [2019] The purpose of this study was to assess the feasibility and safety of intracardiac echocardiography to guide transseptal puncture for radiofrequency catheter ablation.

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

Feasibility and safety of noninvasive pacemaker stress echocardiography with externally triggered stimulation. [2016] The aim of this study was to assess the feasibility and safety of stress echocardiography by triggering an implanted pacemaker through an external stimulator. The implanted pacemaker was set in triggered mode with unipolar sensitivity of

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

Technology update: intracardiac echocardiography - a review of the literature. [2020] The development of new imaging tools helps in better investigation of cardiac structures and function by showing detailed images during interventional procedures. Intracardiac echocardiography plays a pivotal role as an intraoperative real-time imaging tool during invasive cardiac procedures. Initially, this echocardiographic technique was particularly useful when transthoracic image quality was insufficient and to avoid general anesthesia for transesophageal imaging. Nowadays, intracardiac echocardiography is routinely used in several cardiac invasive laboratories to support several types of procedures, such as extraction and implantation of cardiac devices, electrophysiological mapping, ablation, and endomyocardial biopsies. This review gives an overview of the basic principles of intracardiac echocardiography and examines its applications in the different settings of invasive cardiology.