CompletedNot Applicable

Atrial Synchrony Evaluation of Bachmann Bundle Pacing in Sick Sinus Syndrome

China72 participantsStarted 2023-01-01

Plain-language summary

This is a prospective, randomized study to compare the effects of Bachmann bundle pacing (BBP) versus conventional right atrial appendage (RAA) pacing on atrial electromechanical synchrony in patients with sick sinus syndrome (SSS). The study utilizes two-dimensional speckle tracking imaging (2D-STI) to assess improvements in cardiac function and synchrony, aiming to determine a more optimal pacing site for SSS patients.

Who can participate

Age range

30 Years – 90 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: * Meets diagnostic criteria for sick sinus syndrome (e.g., persistent sinus bradycardia \<50 bpm, sinus arrest, sinoatrial block, or tachy-brady syndrome). * Age between 30 and 90 years. * Has not taken any other antiarrhythmic drugs within one month prior to enrollment. * Has not participated in any other related clinical trials. * Voluntarily signs the informed consent form. Exclusion Criteria: * Patients with severe primary diseases causing unstable vital signs (e.g., severe circulatory, digestive, or neurological system diseases). * Patients with a history of recurrent syncope, Adams-Stokes syndrome, severe bradycardia (lowest sinus rhythm \<30 bpm), or long RR interval \>3s. * Pregnant or lactating women. * Patients with mental illness.

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

Change in Inter-atrial Electromechanical Delay (Inter AEMD)

Timeframe: Baseline, 1 Month Post-procedure, 3 Months Post-procedure

Change in Intra-atrial Mechanical Delay (IAMD)

Timeframe: Baseline, 1 Month Post-procedure, 3 Months Post-procedure

Change in Intra-right Atrial Electromechanical Delay (Intra-right AEMD)

Timeframe: Baseline, 1 Month Post-procedure, 3 Months Post-procedure

Trial details

NCT IDNCT07055035

SponsorShiyan City Renmin Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-04-30

View on ClinicalTrials.gov More Sick Sinus Syndrome trials

Plain-language summary

Who can participate

Age range

30 Years – 90 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.

What they're measuring

Change in Inter-atrial Electromechanical Delay (Inter AEMD)

Timeframe: Baseline, 1 Month Post-procedure, 3 Months Post-procedure

Change in Intra-atrial Mechanical Delay (IAMD)

Timeframe: Baseline, 1 Month Post-procedure, 3 Months Post-procedure

Change in Intra-right Atrial Electromechanical Delay (Intra-right AEMD)

Timeframe: Baseline, 1 Month Post-procedure, 3 Months Post-procedure