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

A study testing Heart Ultrasound in people with Heart Failure, run by Geisinger Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Heart Failure
What is being tested?: Heart Ultrasound
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2023to 27 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Geisinger Clinic
Wilkes-Barre, Pennsylvania, 18711

Other trials in United States

About this study

Official title: 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:

Does this help the doctors with figuring out the wire location during implantation?
Does this reduce the wire placement procedure time?
Does this reduce the x-ray imaging time during the procedure?

Participants will be asked to:

Have a physical exam and Echocardiogram (ECG) at initial visit, 2 weeks post implant, and 3 months post implant.
Have a urine pregnancy test (if applicable)
Have a heart ultrasound during implant procedure
Answer questions related to heart failure symptoms to see what stage of heart failure is present
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.

Read the 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
Being tested: Heart Ultrasound
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Heart UltrasoundDevice
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.

Study groups in NCT05646251
Study group	Role	What they receive
EC-LBBAP Participant	Experimental	A heart ultrasound will be used during a pacemaker implant procedure Receives: 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 Receives: Device: Heart Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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)
Measured: Through study completion, an average of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202327 Oct 2024

First posted12 Dec 2022
Study start1 Mar 2023
Primary completion24 Jun 2024
Study completion27 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05646251
Sponsor's protocol ID: 2022-0917
Acronym: EC-LBBAP
Status last verified: Sep 2025
First submitted: 2 Dec 2022
Last updated: 1 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Data will not be shared in an identifiable way.

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. 2025 Sep;22(9):e746-e753. doi: 10.1016/j.hrthm.2024.12.039. Epub 2024 Dec 31.
PubMed 39746387

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intra-procedural Transthoracic EChocardiogram to Facilitate LBBAP
ClinicalTrials.gov ID: NCT05646251
Acronym / sponsor ID: EC-LBBAP / 2022-0917
Conditions: Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Geisinger ClinicUniversity, hospital or other
Collaborators: Medtronic
Study start: 1 Mar 2023 (actual)
Primary completion: 24 Jun 2024 (actual)
Study completion: 27 Oct 2024 (actual)
First posted: 12 Dec 2022 (actual)
Results: Posted 1 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Does this help the doctors with figuring out the wire location during implantation?
Does this reduce the wire placement procedure time?
Does this reduce the x-ray imaging time during the procedure?

Participants will be asked to:

Have a physical exam and Echocardiogram (ECG) at initial visit, 2 weeks post implant, and 3 months post implant.
Have a urine pregnancy test (if applicable)
Have a heart ultrasound during implant procedure
Answer questions related to heart failure symptoms to see what stage of heart failure is present
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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
EC-LBBAP Participant	Experimental	Device: Heart UltrasoundA heart ultrasound will be used during a pacemaker implant procedure
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	Device: Heart UltrasoundA heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Heart UltrasoundA 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.	Device	EC-LBBAP Participant, ECLBBAP handheld participant

Primary outcome

A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram
Time frame: Perioperative, through study completion, an average of 3 months
Positive success rate of LBBAP is measured by Left bundle branch capture for participants, measured during implant
Difference of Fluoroscopy/Procedure Duration Between Groups
Time frame: Perioperative
Difference in fluoroscopy and procedure duration using echo guided LBBAP lead implantation compared to control data for standard LBBAP lead implantation
Number of Participants Determined to be Eligible for the Work-flow and Echocardiographic Procedures
Time frame: Through study completion, an average of 3 months
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)

Results and safety

Results posted to the registry on 1 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EC-LBBAP Participant	21	20
Control Participant	30	30
ECLBBAP Handheld Participant	12	10

Primary outcome: A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram

Time frame: Perioperative, through study completion, an average of 3 months. Count of participants. Unit: Participants

Measure	EC-LBBAP Participant n = 20	EC-LBBAP Handheld Participant n = 10
Value	19	10

Primary outcome: Difference of Fluoroscopy/Procedure Duration Between Groups

Time frame: Perioperative. Median (Standard Deviation). Unit: min

Measure	EC-LBBAP Participant n = 20	EC-LBBAP Handheld Participant n = 10	Standard LBBP n = 30
Procedure duration	101 (27)	89 (29)	95 (39)
Fluoroscopy duration	8.9 (7.9)	10.1 (6.5)	13.5 (8.5)

Primary outcome: Number of Participants Determined to be Eligible for the Work-flow and Echocardiographic Procedures

Time frame: Through study completion, an average of 3 months. Number. Unit: participants

Measure	EC-LBBAP Participant n = 20	EC-LBBAP Handheld Participant n = 10
Value	20	10

Population analysed: Workflow defined and echo images obtained to facilitate LBBAP in participants in the ECLBBAP arm

Adverse events

Time frame: Adverse events were collected during study participation up to final study visit at 3 months post implant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EC-LBBAP Participant	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Control Participant	0 of 30 (0%)	0 of 30 (0%)	0 of 30
ECLBBAP Handheld Participant	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39746387Vijayaraman 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.
Individual participant dataSharing planned: No. Data will not be shared in an identifiable way.

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pugazhendhi Vijayaraman, MD principal investigator

Geisinger Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Heart Ultrasound in people with Heart Failure, run by Geisinger Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram (time frame: Perioperative, through study completion, an average of 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05646251, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.