CompletedNot Applicable

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

United States33 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

A Positive Success Rate of LBBAP Utilization With Intraprocedural Transthoracic Echocardiogram

Timeframe: Perioperative, through study completion, an average of 3 months

Difference of Fluoroscopy/Procedure Duration Between Groups

Timeframe: Perioperative

Number of Participants Determined to be Eligible for the Work-flow and Echocardiographic Procedures

Timeframe: Through study completion, an average of 3 months

Trial details

NCT IDNCT05646251

SponsorGeisinger Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-24

Results submitted2025-06-24

View on ClinicalTrials.gov More Heart Failure trials