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

NCT05646251 | Completed Results FDA Device

• 1 other identifier: 2022-0917
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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. 1.Does this help the doctors with figuring out the wire location during implantation?
2. 2.Does this reduce the wire placement procedure time?
3. 3.Does this reduce the x-ray imaging time during the procedure?
4. 4.Have a physical exam and Echocardiogram (ECG) at initial visit, 2 weeks post implant, and 3 months post implant.
5. 5.Have a urine pregnancy test (if applicable)
6. 6.Have a heart ultrasound during implant procedure
7. 7.Answer questions related to heart failure symptoms to see what stage of heart failure is present
8. 8.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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

EC-LBBAP Participant

EXPERIMENTAL

A heart ultrasound will be used during a pacemaker implant procedure

Device: Heart Ultrasound

Control participant

NO INTERVENTION

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

ECLBBAP handheld participant

EXPERIMENTAL

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

Device: Heart Ultrasound

Interventions

Heart Ultrasound 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.

EC-LBBAP Participant; ECLBBAP handheld participant

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Geisinger Clinic: lead
• Medtronic: collaborator

Study Sites (1)

Geisinger Clinic

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Related Publications (1)

• 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.

  PMID: 39746387 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Results Point of Contact

• Title: Dr Pugazhendhi Vijayaraman
• Organization: Geisinger

pvijayaraman1@geisinger.edu

5708086020

Study Officials

• Pugazhendhi Vijayaraman, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 retrospectively identify 30 consecutive previous patients who satisfy inclusion and exclusion criteria (control patients). The study team will compare the difference in procedural success between Case and Control patients.

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: March 1, 2023
• Primary Completion: June 24, 2024
• Study Completion: October 27, 2024
• Last Updated: October 1, 2025
• Results First Posted: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)