N/A
N=63
Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT05646251 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram — 19; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heart Ultrasound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Geisinger Clinic
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram |
19; 10 | — |
| PRIMARY Difference of Fluoroscopy/Procedure Duration Between Groups |
101; 89; 95; 8.9; 10.1; 13.5 | — |
| PRIMARY Number of Participants Determined to be Eligible for the Work-flow and Echocardiographic Procedures |
20; 10 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05646251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.