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

Heart Failure Clinical Trial

— EC-LBBAP  

Official title:

Intra-procedural Transthoracic EChocardiogram to Facilitate LBBAP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646251
• Other study ID #: 2022-0917
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: January 15, 2026

Study information

• Verified date: July 2023
• Source: Geisinger Clinic
• Contact: Pugazhendhi Vijayaraman, MD
• Phone: 570-808-6020
• Email: pvijayaraman1[@]geisinger.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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). The study team will compare the difference in procedural success between case and control patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Geisinger Clinic	Wilkes-Barre	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Geisinger Clinic	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A positive success rate of LBBAP utilization with intraprocedural transthoracic echocardiogram		15 Months
Primary	Change of fluoroscopy/procedure duration	Change using LBBAP lead implantation compared to historic data from prior Geisinger studies utilizing LBBAP	15 Months
Primary	Identification of work-flow and echocardiographic windows to facilitate LBBAP		15 Months