Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-06 @ 6:43 PM
Study NCT ID:
NCT05646251
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2022-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)
Sponsor:
Geisinger Clinic
Organization:
Study Overview
Official Title:
Intra-procedural Transthoracic EChocardiogram to Facilitate LBBAP
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EC-LBBAP
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. 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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: