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

NCT ID: NCT05646251

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-10-27

Brief Summary

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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EC-LBBAP Participant

A heart ultrasound will be used during a pacemaker implant procedure

Group Type: EXPERIMENTAL

Heart Ultrasound

Intervention Type: DEVICE

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.

Control participant

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

ECLBBAP handheld participant

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

Group Type: EXPERIMENTAL

Heart Ultrasound

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pugazhendhi Vijayaraman, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Clinic

Wilkes-Barre, Pennsylvania, United States

Countries

United States

References

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. 2025 Sep;22(9):e746-e753. doi: 10.1016/j.hrthm.2024.12.039. Epub 2024 Dec 31.

Reference Type: DERIVED

PMID: 39746387 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2022-0917

Identifier Type: -

Identifier Source: org_study_id