Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left … (NCT07526896) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
80 participantsStarted 2026-08
Plain-language summary
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ).
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:
* Subject meets current ACC/AHA/HRS guidelines for implantation of a CRT-D device.
* Subject has documented LVEF ≤ 35% within 60 days of enrollment.
* Subject meets the criteria for presence of Strauss-defined LBBB.
* Subject meets NYHA classification II or III.
* Subject is willing and able to provide written consent.
* Subject is at least 18 years of age at the time of consent.
* Subject is geographically stable and willing and able to complete study procedures, including follow-up visits.
* The subject's medical records must be accessible by the enrolling site over the follow-up period.
Exclusion Criteria:
* Subject has documented myocardial infarction before enrollment.
* Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.
* Subject has 2nd or 3rd degree AV block.
* Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).
* Subject has intrinsic (non-paced) QRS duration ≤ 120ms.
* Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads.
* Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).
* Subject underwent valve surgery within 90 days prior to enrollment.
* Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or…
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.