Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP) (EC-LBBAP)

Intra-procedural Transthoracic EChocardiogram to Facilitate LBBAP

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Heart Ultrasound

Detailed Description

The EC-LBBAP study is a prospective, single-enter, observational research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the feasibility and success rates of echocardiogram guided LBBAP lead implantation.

Eligible patients will undergo LBBAP using Medtronic 3830 lead and C315His sheath. LBBAP will be confirmed at implant using left bundle potentials recorded from the lead, ECG morphology during unipolar and bipolar pacing, peak Left Ventricular Pacing (LV) activation time and lead depth in the 2D transthoracic echo at implant.

During implant procedure, transthoracic echo windows will be identified and documented: Parasternal short and long axis, apical 2 and 4 chamber views and subcostal views to visualize the proximal interventricular septum. Following venous access using cephalic vein cut-down or ultrasound guided axillary vein access, the lead implantation in the left bundle branch region will be guided by echocardiography.

Retrospectively, the study team will identify 20 consecutive previous patients who satisfy inclusion and exclusion criteria (control patients). Twenty patients will undergo intraprocedural transthoracic echocardiogram via standard practices. An additional 10 patients will undergo intraprocedural transthoracic echocardiogram using a hand-held ultrasound device. The study team will compare the difference in procedural success between case and control patients.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Potential participants will be identified by clinician referrals. Research staff will contract potential subjects and invite them to participate.

Description

Inclusion Criteria:

• patient with indication for permanent pacemaker or Implantable Cardioverter Defibrillator (ICD) utilizing conduction system pacing lead for bradycardia or cardiac resynchronization therapy
• patient is willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

• Inability to provide informed consent
• pregnant
• enrolled in a concurrent study that may confound the results of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EC-LBBAP Participant; A heart ultrasound will be used during a pacemaker implant procedure	Device: Heart Ultrasound; A wand is placed on the chest to use soundwaves to make a picture of the heart and shows how the muscle and valves work. This helps with device placement.
No Intervention: Control participant; A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm.
Experimental: ECLBBAP handheld participant; A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure	Device: Heart Ultrasound; A wand is placed on the chest to use soundwaves to make a picture of the heart and shows how the muscle and valves work. This helps with device placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram	Positive success rate of LBBAP is measured by Left bundle branch capture for participants, measured during implant	Perioperative, through study completion, an average of 3 months
Difference of Fluoroscopy/Procedure Duration Between Groups	Difference in fluoroscopy and procedure duration using echo guided LBBAP lead implantation compared to control data for standard LBBAP lead implantation	Perioperative
Number of Participants Determined to be Eligible for the Work-flow and Echocardiographic Procedures	This measure is to determine if the workflow is feasible in regular practice (echo tech availability, lab availability, duration of comparative procedures) between intervention group and controls, and to determine if the identifying echocardiographic windows is able to be performed pre operatively on all intervention patients This measure is to determine the number of participants that the workflow is feasible for and could be performed on in regular practice (echo tech availability, lab availability, duration of comparative procedures)	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: Medtronic
• Investigators: Principal Investigator: Pugazhendhi Vijayaraman, MD, Geisinger Clinic

Publications and helpful links

General Publications

• Vijayaraman P, Hughes G, Manganiello M, Leri G, Laver A, Sacco K, Mroczka K, Schmidt E, Mascarenhas VH. Intraprocedural transthoracic EChocardiography to facilitate Left Bundle Branch Pacing: EC-LBBP. Heart Rhythm. 2024 Dec 31:S1547-5271(24)03712-3. doi: 10.1016/j.hrthm.2024.12.039. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): June 24, 2024
• Study Completion (Actual): October 27, 2024

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: 2022-0917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared in an identifiable way.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No