REstoration of SYNChronous Cardiac Function Due to Physiologic cArdiac Pacing Modalities With Cli… (NCT07684547) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
REstoration of SYNChronous Cardiac Function Due to Physiologic cArdiac Pacing Modalities With Clinical Endpoints
Hungary50 participantsStarted 2026-06-29
Plain-language summary
The goal of this observational study is to evaluate the long-term clinical outcomes of physiologic cardiac resynchronization therapy (CRT) using conduction system pacing strategies compared with conventional biventricular CRT in patients with heart failure with reduced ejection fraction (HFrEF) and electrical dyssynchrony.
The main questions it aims to answer are:
* Does physiologic CRT (including left bundle branch area pacing \[LBBAP\] and LBBAP-optimized CRT) reduce the combined risk of all-cause mortality and heart failure hospitalization compared with conventional biventricular CRT?
* Does physiologic CRT improve cardiac function and reverse ventricular remodeling more effectively than conventional CRT?
Participants receiving physiologic CRT as part of routine clinical care will undergo standard follow-up evaluations, including electrocardiography, echocardiography, laboratory testing, and device interrogation. Clinical outcomes will be collected prospectively for 24 months and compared with a historical cohort of patients treated with conventional biventricular CRT.
The study will assess clinical outcomes, echocardiographic response, electrical resynchronization parameters, and device-related safety in a real-world heart failure population.
Who can participate
Age range
18 Years – 100 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:
* Age ≥18 years.
* Symptomatic heart failure despite guideline-directed medical therapy.
* Left ventricular ejection fraction (LVEF) ≤40%.
* Indication for cardiac resynchronization therapy according to contemporary ESC guideline recommendations.
* QRS duration ≥150 ms with either:
Left bundle branch block (LBBB), or Intraventricular conduction delay (IVCD).
* Planned implantation of a CRT system
* Ability to provide written informed consent
* Expected survival greater than 24 months.
Exclusion Criteria:
* Age \<18 years and Age 100 \< years
* Pregnancy or breastfeeding.
* Inability or unwillingness to provide informed consent.
* Life expectancy \<12 months due to non-cardiac comorbidities.
* Active systemic infection or infection involving a cardiac implantable electronic device.
* Reversible causes of heart failure expected to improve without CRT.
* Participation in another interventional clinical trial that may affect study outcomes.
* Inability to comply with follow-up requirements.
* Missing essential baseline or follow-up data (retrospective cohort).
* Any condition that, in the opinion of the investigators, would make participation inappropriate or interfere with study assessments.
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
Composite of All-Cause Mortality and Heart Failure Hospitalization