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

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Perioperative, through study completion, an average of 3 months

Results posted on

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

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

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

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
Sex: Female, Male Male	10 Participants n=5 Participants	19 Participants n=7 Participants	6 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Continuous	71.35 years STANDARD_DEVIATION 10.236 • n=5 Participants	77.06 years STANDARD_DEVIATION 9.18 • n=7 Participants	72.8 years STANDARD_DEVIATION 12.5 • n=5 Participants	74.45 years STANDARD_DEVIATION 10.31 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	25 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	28 Participants n=7 Participants	10 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
BMI	29.8 kg/m^2 STANDARD_DEVIATION 5.63 • n=5 Participants	28.74 kg/m^2 STANDARD_DEVIATION 5.27 • n=7 Participants	26.9 kg/m^2 STANDARD_DEVIATION 6.48 • n=5 Participants	28.8 kg/m^2 STANDARD_DEVIATION 5.58 • n=4 Participants
Hypertension	17 Participants n=5 Participants	28 Participants n=7 Participants	10 Participants n=5 Participants	55 Participants n=4 Participants
Diabetes	5 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	20 Participants n=4 Participants
Coronary artery disease	9 Participants n=5 Participants	12 Participants n=7 Participants	3 Participants n=5 Participants	24 Participants n=4 Participants
Atrial Fibrillation	15 Participants n=5 Participants	21 Participants n=7 Participants	5 Participants n=5 Participants	41 Participants n=4 Participants
Cardiomyopathy	7 Participants n=5 Participants	21 Participants n=7 Participants	5 Participants n=5 Participants	33 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

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: Perioperative

Difference in fluoroscopy and procedure duration using echo guided LBBAP lead implantation compared to control data for standard LBBAP lead implantation

Outcome measures

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 months

Population: 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

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Participant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ECLBBAP Handheld Participant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Pugazhendhi Vijayaraman

Geisinger

Phone: 5708086020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place