Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular B… (NCT04624763) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block
China683 participantsStarted 2021-06-22
Plain-language summary
OptimPacing study has been designed as a prospective, multi-center, randomized, controlled trial. A total of 11 medical centers across China will enroll 683 patients over an estimated recruitment period of 2 years. An LBBP group will be compared with a group of conventional RVP in the follow-up of at least 3 years. The study aimed to demonstrate (1) the superiority of LBBP in preserving LV systolic function over RVP and (2) the feasibility and long-term safety of LBBP in patients with AV block.
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
. Indication of permanent pacemaker implantation: (1) Second degree or complete AV block; (2) Persistent or permanent atrial fibrillation with mean ventricular rate \< 50 bpm and related symptoms
. LVEF \> 35%, NYHA classification I-III
. Age \> 18 years
. Signed informed consent
Exclusion criteria
. Implanted prosthetic tricuspid valve
. Unstable angina, acute myocardial infarction, CABG or PCI within the last 3 months
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
A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)
Timeframe: 6-month follow-up
2
A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)
Timeframe: 12-month follow-up
3
A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)
Timeframe: 24-month follow-up
4
A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM)
Timeframe: 36-month follow-up
Trial details
NCT IDNCT04624763
SponsorThe First Affiliated Hospital with Nanjing Medical University