Active — Not RecruitingNot Applicable

Pacing Characteristics of a Conventional Bipolar

Taiwan134 participantsStarted 2023-01-01

Plain-language summary

Study Title: Pacing characteristics of a conventional bipolar, active fixation pacing lead for left bundle branch area pacing in patients with symptomatic bradycardia Study Objectives: To characterize an approach for left bundle branch area pacing (LBBAP) in patients with bradycardia indications for pacing and to assess implant success rate, safety, and long-term stability with a conventional bipolar, active fixation pacing lead. Methodology: Open-label, prospective, multi-center, non-randomized, single-arm study Study Endpoints: Primary Endpoint: • Implant success rate Secondary Endpoints: * Intra-operative procedure time and fluoroscopic exposure time * Intra-operative intracardiac electrogram (EGM) changes: paced QRS duration, stimulus to left ventricular (LV) activation time, and LBB potential * Post-operative imaging data: posteroanterior, left anterior oblique 30O, right anterior oblique 30O, Left lateral views * Serial paced 12-lead electrocardiogram (ECG) and intracardiac EGM changes: QRS duration (QRSd), pacing-QRS interval, and new atrial ﬁbrillation (AF) * Serial echocardiography changes: left ventricular ejection fraction (LVEF), left atrial (LA) and LV chamber size, and global longitudinal strain (GLS) of tissue Doppler imaging * Serial changes of pacing parameters: capture threshold, impedance, and sensing amplitude for both atrial and ventricular Solia S leads * Safety: Immediate (\< 24 hours), in-hospital, and chronic (12 months) adverse events

Who can participate

Age range

20 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: * Adult patients ≥ 20 years of age * Standard bradycardia pacing indications requiring new ventricular lead implantation * Able to give informed consent for the participation in the trial Exclusion Criteria: * Patients underwent cardiac resynchronization therapy or implantable cardioverter-defibrillator implantation * New York Heart Association (NYHA) functional class IV heart failure * Life expectancy \< 1 year * Right-sided approach for lead implantation * Hemodialysis or peritoneal dialysis patients * Pregnant or breast-feeding women * Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints * Participation in another prospective interventional clinical study within a period of 4 weeks prior to the implantation of LBBAP * Use of any recreational drugs or history of drug addiction * Any other condition that, in the investigator's judgment, might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the 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

Implant Success Rate

Timeframe: Baseline, 12 months

Trial details

NCT IDNCT06011252

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Symptomatic Bradycardia trials