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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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:
Participants will be asked to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EC-LBBAP Participant | Experimental | A 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 | A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pugazhendhi Vijayaraman, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Clinic | Wilkes-Barre | Pennsylvania | 18711 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39746387 | Derived | 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. |
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Data will not be shared in an identifiable way.
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21 EC-LBBAP participants were consented and enrolled in the study. One participant did not complete the study and was exited, as echo was unable to be complete at implant.
12 EC-LBBAP handheld participants were consented and enrolled in the study. Two participants did not complete the study and were exited, as echo was unable to be complete at implant.
30 Participants in the "Control" Arm/Group are not considered enrolled and therefore, not included in the Number Enrolled.
Potential participants will be identified by clinician referrals at Geisinger Wyoming Valley Heart Hosptial. Research staff will contact potential subjects and invite them to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | EC-LBBAP Participant | A heart ultrasound will be used during a pacemaker implant procedure |
| FG001 | Control Participant | A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm. |
| FG002 | ECLBBAP Handheld Participant | A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EC-LBBAP Participant | A heart ultrasound will be used during a pacemaker implant procedure |
| BG001 | Control Participant | A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Perioperative, through study completion, an average of 3 months |
|
Adverse events were collected during study participation up to final study visit at 3 months post implant.
Patients will be asked about adverse events related to the use of the echocardiography. Only echocardiogram related adverse event will be collected and reported and then assessed if it is procedure related, as well as all-cause mortality and serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EC-LBBAP Participant | A heart ultrasound will be used during a pacemaker implant procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pugazhendhi Vijayaraman | Geisinger | 5708086020 | pvijayaraman1@geisinger.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2024 | May 22, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2024 | May 22, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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| BG002 | ECLBBAP Handheld Participant | A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Coronary artery disease | Count of Participants | Participants |
|
| Atrial Fibrillation | Count of Participants | Participants |
|
| Cardiomyopathy | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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 | Posted | Median | Standard Deviation | min | Perioperative |
|
|
|
| Primary | 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) | Workflow defined and echo images obtained to facilitate LBBAP in participants in the ECLBBAP arm | Posted | Number | participants | Through study completion, an average of 3 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control Participant | A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | ECLBBAP Handheld Participant | A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure | 0 | 10 | 0 | 10 | 0 | 10 |
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| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
|