Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Fa… (NCT05572736) | Clinical Trial Compass
CompletedNot Applicable
Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure
Brazil179 participantsStarted 2022-11-07
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of conduction system pacing versus biventricular pacing in patients with chronic heart failure with reduced ejection fraction and left bundle branch 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:
* Male or female, age ≥18 years
* Established diagnosis of symptomatic heart failure (New York Heart Association class II-III)
* Left ventricular ejection fraction ≤35% in prior 3 months
* Left bundle branch block (QRS ≥130 ms)
* Clinical indication for cardiac resynchronization therapy
* Patients should be clinically stable
* Patients should receive background standard of care for heart failure with reduced ejection fraction, with the maximum tolerated doses of ACE inhibitor or ARB or ARNI, beta-blocker, and mineralocorticoid receptor antagonist
Exclusion criteria:
* Life expectancy \<12 months due to any disease
* Dementia or advanced cerebrovascular disease
* NYHA class IV
* Plan to implant an implantable cardioverter defibrillator (ICD), with or without resynchronization therapy (CRT-D)
* Enrollment in other clinical trials involving cardiac pacing
* Pregnancy or pre-menopausal women who do not use regular contraceptive methods
* Patients unable to understand and sign the consent for 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.