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

NCT05646251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-10-01

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Geisinger Clinic

    lead OTHER

Principal Investigators

  • Pugazhendhi Vijayaraman, MD · Geisinger Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-06-24
Completion
2024-10-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646251 on ClinicalTrials.gov