ECG and Echo Characteristics of BBAP (NCT06995027) | Clinical Trial Compass
CompletedNot Applicable
ECG and Echo Characteristics of BBAP
China31 participantsStarted 2024-08-31
Plain-language summary
This is a prospective, single-site, non-randomized, interventional study. The purpose is to collect electrocardiographic (ECG) and echocardiographic (echo) parameters and computed tomography (CT) images (optional) during Bachmann's bundle area pacing (BBAP) and conventional pacing in the right atrial appendage (RAA) to compare the differences between atrial pacing modalities and to further investigate the clinical outcomes of BBAP.
Who can participate
Age range
18 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:
* Patients aged \>= 18 years old
* Patients who are willing to provide Informed Consent
* Patients who are indicated to atrial pacing, dual-chamber pacing, or cardiac resynchronization therapy
* Patients who consent to Bachmann's bundle area pacing
Exclusion Criteria:
* Patients who are indicated for cardiac implantable electronic device replacement or upgrade
* Patients with defibrillation indications
* Patients who are pregnant or have a plan for pregnancy during the study
* Patients who have medical conditions that would limit study participation
* Patients who were already enrolled in other trials which would impact his/her participation
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
1
Atrial-paced ECG P-wave duration at implantation and during regular follow-ups
Timeframe: From implantation to regular follow-ups up to 6 months
2
Atrial-paced ECG P-wave amplitude at implantation and during regular follow-ups
Timeframe: From implantation to regular follow-ups up to 6 months
3
Atrial-paced P-onset to A-wave initiation time under Doppler at mitral and tricuspid valves at implantation