Trial Outcomes & Findings for Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP) (NCT NCT05646251)
NCT ID: NCT05646251
Last Updated: 2025-10-01
Results Overview
Positive success rate of LBBAP is measured by Left bundle branch capture for participants, measured during implant
COMPLETED
NA
33 participants
Perioperative, through study completion, an average of 3 months
2025-10-01
Participant Flow
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.
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.
Participant milestones
| Measure |
EC-LBBAP Participant
A heart ultrasound will be used during a pacemaker implant procedure
|
Control Participant
A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm.
|
ECLBBAP Handheld Participant
A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
30
|
12
|
|
Overall Study
COMPLETED
|
20
|
30
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
EC-LBBAP Participant
A heart ultrasound will be used during a pacemaker implant procedure
|
Control Participant
A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm.
|
ECLBBAP Handheld Participant
A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
2
|
Baseline Characteristics
Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)
Baseline characteristics by cohort
| Measure |
EC-LBBAP Participant
n=20 Participants
A heart ultrasound will be used during a pacemaker implant procedure
|
Control Participant
n=30 Participants
A pacemaker will be implanted using routine protocol. This is retrospectively collected; patients are not actively enrolled in this arm.
|
ECLBBAP Handheld Participant
n=10 Participants
A heart ultrasound using a handheld ultrasound device will be used during a pacemaker implant procedure
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.35 years
STANDARD_DEVIATION 10.236 • n=99 Participants
|
77.06 years
STANDARD_DEVIATION 9.18 • n=107 Participants
|
72.8 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
74.45 years
STANDARD_DEVIATION 10.31 • n=157 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
25 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
35 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
58 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
BMI
|
29.8 kg/m^2
STANDARD_DEVIATION 5.63 • n=99 Participants
|
28.74 kg/m^2
STANDARD_DEVIATION 5.27 • n=107 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 6.48 • n=206 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 5.58 • n=157 Participants
|
|
Hypertension
|
17 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
55 Participants
n=157 Participants
|
|
Diabetes
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
20 Participants
n=157 Participants
|
|
Coronary artery disease
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
24 Participants
n=157 Participants
|
|
Atrial Fibrillation
|
15 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
41 Participants
n=157 Participants
|
|
Cardiomyopathy
|
7 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
33 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Perioperative, through study completion, an average of 3 monthsPositive success rate of LBBAP is measured by Left bundle branch capture for participants, measured during implant
Outcome measures
| Measure |
EC-LBBAP Participant
n=20 Participants
Patients undergoing pacemaker insertion using ultrasound guided left bundle branch pacing
|
EC-LBBAP Handheld Participant
n=10 Participants
Patients undergoing pacemaker insertion using handheld ultrasound guided left bundle branch pacing
|
Standard LBBP
Patients undergoing pacemaker insertion using standard practice for left bundle branch pacing
|
|---|---|---|---|
|
A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram
|
19 Participants
|
10 Participants
|
—
|
PRIMARY outcome
Timeframe: PerioperativeDifference in fluoroscopy and procedure duration using echo guided LBBAP lead implantation compared to control data for standard LBBAP lead implantation
Outcome measures
| Measure |
EC-LBBAP Participant
n=20 Participants
Patients undergoing pacemaker insertion using ultrasound guided left bundle branch pacing
|
EC-LBBAP Handheld Participant
n=10 Participants
Patients undergoing pacemaker insertion using handheld ultrasound guided left bundle branch pacing
|
Standard LBBP
n=30 Participants
Patients undergoing pacemaker insertion using standard practice for left bundle branch pacing
|
|---|---|---|---|
|
Difference of Fluoroscopy/Procedure Duration Between Groups
Procedure duration
|
101 min
Standard Deviation 27
|
89 min
Standard Deviation 29
|
95 min
Standard Deviation 39
|
|
Difference of Fluoroscopy/Procedure Duration Between Groups
Fluoroscopy duration
|
8.9 min
Standard Deviation 7.9
|
10.1 min
Standard Deviation 6.5
|
13.5 min
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: Through study completion, an average of 3 monthsPopulation: Workflow defined and echo images obtained to facilitate LBBAP in participants in the ECLBBAP arm
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)
Outcome measures
| Measure |
EC-LBBAP Participant
n=20 Participants
Patients undergoing pacemaker insertion using ultrasound guided left bundle branch pacing
|
EC-LBBAP Handheld Participant
n=10 Participants
Patients undergoing pacemaker insertion using handheld ultrasound guided left bundle branch pacing
|
Standard LBBP
Patients undergoing pacemaker insertion using standard practice for left bundle branch pacing
|
|---|---|---|---|
|
Number of Participants Determined to be Eligible for the Work-flow and Echocardiographic Procedures
|
20 participants
|
10 participants
|
—
|
Adverse Events
EC-LBBAP Participant
Control Participant
ECLBBAP Handheld Participant
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place