Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding pacing to the heart’s lower left chamber works better than left bundle branch area pacing alone. Both treatments use an implanted device that helps the heart beat in sync and can treat dangerous heart rhythms. It is for adults with heart failure and left bundle branch block, an electrical signal delay, who qualify for this device.
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). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Meet current medical guidelines for a CRT-D, a device that helps the heart beat in sync and treats dangerous rhythms.
- Have a heart pumping strength of 35% or less, measured within 60 days before joining.
- Have left bundle branch block that meets the study’s specific rules.
- Have class II or III heart failure, meaning symptoms limit physical activity.
- Be willing and able to sign a consent form.
- Be at least 18 years old.
- Live in a stable location and be willing and able to complete study tests and follow-up visits.
- Allow the study site to access your medical records during follow-up.
Who can't join
- Have had a heart attack, have a different heart signal delay instead of left bundle branch block, or have a natural heart electrical signal lasting 120 milliseconds or less.
- Have second- or third-degree heart block, where signals between the heart’s upper and lower chambers are slowed or blocked, or ongoing atrial fibrillation or flutter, which are abnormal heart rhythms.
- Have or previously had a pacemaker, a defibrillator placed through a vein, a CRT-D, or their wires; or cannot safely have screw-in wires placed through a vein.
- Had heart valve surgery within 90 days before joining, or cannot or will not have a heart MRI when suitable past images are not available.
- Have had a heart transplant, are on the transplant waiting list, or have an implanted pump that helps the heart’s lower left chamber.
- Have severe kidney disease, need a nonstop infusion of medicine to strengthen the heartbeat, or have a complex heart defect present since birth that has not been repaired.
- Are expected to live less than 12 months, are pregnant, or are breastfeeding.
- Are in or plan to join another study that could affect these results, unless a Medtronic study manager has given written approval.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 do not meet minimum acceptable criteria. * Subject is post-heart transplantation or is actively listed on the transplantation list. * Subject is implanted with a left ventricular assist device (LVAD). * Subject has severe renal disease. * Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure. * Subject has complex and uncorrected congenital heart disease. * Subject has life expectancy of less than 12 months. * Subject is pregnant or breastfeeding. * Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
Study sites (1)
MN
- Minneapolis Heart Institute Foundation · Minneapolis, MN 55407Ellen Thomas · Study contactJohn Zakaib · Principal investigatorMore trials in Minneapolis